An Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics and Conspicuity of Bludigo® When Used as an Aid in the Determination of Ureteral Patency in Pediatric Patients

This is an open-label, multicenter study to evaluate the safety, pharmacokinetics, and conspicuity of a weight-based Bludigo® dose (0.05 mL/kg rounded up (if necessary) to a minimum of 0.5 mL and not to exceed 2.5 mL) when used as an aid in the determination of ureteral patency in pediatric patients.
The study will enroll approximately 18 pediatric patients from approximately 2-3 study centers in the United States.
Patients scheduled for urological or gynecological surgical procedures who are < 17 years will be screened for participation.
A minimum of 6 patients will be enrolled in each of the following three age groups: birth to <6-years old, 6 to < 12 years old, 12 to < 17 years old.
Screening will occur within 30 days before study drug administration (Day of Surgery).
After signing the informed consent, review of inclusion and exclusion criteria will be performed. The collection of medical history and concomitant medications, the completion of a physical examination including vital signs measurement, ECG, and the collection of baseline laboratory testing (samples must be collected within 14 days of day 1) will be completed during the screening period.
On the Day of Surgery (Day 1) patients will be evaluated for eligibility for treatment.
To evaluate the efficacy outcomes, each patient will be injected with a weight-based dose of Bludigo® (0.05 mL/kg rounded up (if necessary) to a minimum of 0.5 mL) the maximum dose to be injected is not to exceed 2.5 mL. The ureteral orifices / urine jet will be observed, and a video will be recorded for 10 minutes. The time that will be captured on video is from the time of Bludigo® injection to 10 minutes post injection. If both ureters cannot be visualized simultaneously, then alternating 15-30 second images of each ureter or ureteral orifice will be obtained. The surgeon should note the time blue color is visualized in each ureter jet stream.
Blood samples for PK analysis Urine samples will be collected at 0-30 minutes and 30 minutes- 2 hours post Bludigo® injection.
All treated patients will have a follow-up visit 14 (± 3) days after the procedure. A final telephone call to assess adverse events (AEs) will occur at Day 30 (±2 days).
Safety assessments will include monitoring of vital signs, AEs and laboratory testing post the procedure.

开始日期2024-06-01

申办/合作机构

Provepharm Life Solutions SA

NCT06085183 / Recruiting临床4期

An Open-Label, Randomized, Parallel Group Study to Investigate the Influence of Renal Impairment on the Efficacy and Safety of Two Doses of Bludigo™ (Indigotindisulfonate Sodium Injection, USP) 0.8% When Used as an Aid in the Determination of Ureteral Patency

This is an open label, randomized, multicenter study to evaluate the efficacy and safety of two dose levels (2.5 mL and 5.0 mL) of Indigotindisulfonate Sodium Injection, USP 0.8% when used as an aid in the determination of ureteral patency in patients with different degrees of renal impairment.

开始日期2023-12-20

申办/合作机构-

NCT06054880 / Recruiting临床4期

An Open-Label, Randomized, Multicenter Study to Evaluate the Safety, Efficacy, and Physician Satisfaction of Two Different Doses of Bludigo™ (Indigotindisulfonate Sodium Injection, USP) 0.8% When Used as an Aid in the Determination of Ureteral Patency

This is a randomized, multicenter study to evaluate the efficacy and safety of two dose levels (2.5 mL and 5.0 mL) of Bludigo™ (indigotindisulfonate Sodium Injection, USP) 0.8% when used as an aid in the determination of ureteral patency.
Subjects scheduled for a surgical procedure in which the patency of the ureter must be assessed by cystoscopy following the procedure, age 18 to 85 years inclusive, will be screened for participation. Screening will occur within 30 days before study drug administration (Day of Surgery). After signing the informed consent, review of inclusion and exclusion criteria will be performed, the collection of concomitant medications, medical history, physical examination, baseline laboratory testing, 12-lead ECG, and vital sign measurements will be completed during the screening visit.
On the day of surgery (Day 1) subjects will be evaluated for eligibility for randomization. Eligible subjects will be stratified by BMI (<30.0 kg/m2or ≥ 30.0 kg/m2) and randomized in a 1:1 ratio to receive a dose of either Bludigo™ high dose (5.0 mL) or Bludigo™ low dose (2.5 mL). Each randomized subject will serve as his/her own control (i.e., intra-patient controlled) by receiving a dose of normal saline prior to receiving the randomized Bludigo™ dose.
All treated subjects will have a follow-up visit 7 to 30 days (± 2 days) after the procedure. A final telephone follow-up call will occur on Day 30 (± 2 days) in subjects who have the follow-up visit before Day 28. Safety assessments will include monitoring of AEs during and post the procedure, clinical laboratory tests, 12-Lead ECG, and vital sign measurements.

开始日期2023-10-12

申办/合作机构-

100 项与 Indigotindisulfonate sodium 相关的临床结果

登录后查看更多信息

100 项与 Indigotindisulfonate sodium 相关的转化医学

登录后查看更多信息

100 项与 Indigotindisulfonate sodium 相关的专利（医药）

登录后查看更多信息

552

项与 Indigotindisulfonate sodium 相关的文献（医药）

2024-02-01·Urology

Surgical Management of Endometriosis Involving the Bladder and Ureter

作者: Khan, Zaraq ; Burnett, Tatnai L ; Cope, Adela G ; Youssef, Youssef ; Anderson, Katherine T ; VanBuren, Wendaline M ; Neblett, Michael F

BACKGROUND:

Endometriosis is a chronic, debilitating condition affecting up to 10% of reproductive-age women. Urinary tract endometriosis is found in 1%-6% of women diagnosed with pelvic endometriosis, with the most common sites being the bladder (70%-85%), ureter (9%-23%), and kidney (4%). Patients typically present with symptoms such as lower abdominal pain, dysuria, and urgency. Unfortunately, urinary tract endometriosis is often asymptomatic, potentially leading to silent obstructive uropathy and kidney failure.

OBJECTIVE:

To demonstrate a step-by-step approach for the surgical management of urinary tract endometriosis using conventional laparoscopy for partial cystectomy and robotic-assisted laparoscopy for ureteroneocystostomy.

MATERIAL AND METHOD:

Surgical video of 2 cases managed in an academic tertiary referral center for endometriosis. The first case was a 38-year-old Gravida 3, Para 3 with a history of hysterectomy who had an MRI which revealed a T2 hypointense bladder nodule consistent with endometriosis. Patient had significant urinary urgency, dysuria, and suprapubpic pain that improved but did not disappear after starting oral progestin therapy (5 mg of norethindrone). A cystoscopy was first performed to confirm MRI findings of bladder lesion and to delineate borders and depth of invasion. The second case was a 35-year-old nulliparous woman with chronic pelvic pain and primary infertility. The patient had a history of stage IV endometriosis with deep endometriosis into the bowel and extrinsic encasement of the ureters causing subsequent hydronephrosis requiring bilateral ureteral stents. She had continued daily pelvic pain despite of being on oral contraceptives for medical management of endometriosis. She subsequently underwent bilateral percutaneous nephrostomy tube placement to allow for ureteral rest prior to surgery.

RESULTS:

In the first case, conventional laparoscopy was utilized to perform bilateral ureterolysis, bladder mobilization, partial cystectomy for complete excision of the lesion, and 2-layered bladder closure. Use of indigo carmine assisted with ureteral orifice identification. In the second case, a cystoscopy was performed with injection of Indocyanine green to assist with ureteral identification. After ureterolysis, distal ureteric obstruction due to extensive disease was confirmed on laparoscopy and ureteroscopy. Bilateral ureteroneocystostomy with placement of Double-J ureteral stents was performed using a robotic-assisted approach. Each patient had an indwelling Foley catheter for bladder decompression during recovery. Pathology in both cases revealed endometriosis. Both patients had an uneventful postoperative course. A postoperative retrograde cystogram confirmed adequate repair prior to removal of each Foley catheter. Patient 2 had uncomplicated office stent removal 6 weeks postoperatively and had a normal renal ultrasound with no hydronephrosis 6 months postoperatively.

CONCLUSION:

Endometriosis is an increasingly common condition. It is important for gynecological surgeons to have the proper understanding of anatomy, surgical technique, and multidisciplinary care needed with urology for safe and complete excision of bladder and ureter endometriosis.

2024-02-01·European journal of obstetrics, gynecology, and reproductive biology

Indigo carmine dye for detecting urinary track damage during vaginal surgery

Article

作者: Debras, Élodie ; Jegaden, Margaux ; Capmas, Perrine ; Fernandez, Hervé ; Pourcelot, Anne-Gaëlle

OBJECTIVE:

Unrecognized ureteral and bladder injury increase morbidity and mortality in gynecologic surgery. The primary objective of this study is to analyze the efficiency of a systematic intra-venous (IV) injection of carmine indigo to detect bladder injury in gynecologic vaginal surgery for benign disease. The secondary objective is to analyze the cost and use of carmine indigo.

STUDY DESIGN:

A retrospective, monocentric study was conducted in a tertiary hospital between January 2018 and October 2021. All patients undergoing a vaginal surgery of hysterectomy for benign disease or anterior prolapse were systematically included. Patients can be systematically included by the automatic coding of surgery. After anesthesia, during the patient's installation, an intravenous injection of 5 mL of intravenous indigo carmine (Carmyne®) diluted in 100 mL of physiological serum was systematically administered by the anesthesia team. Intraoperative cystoscopy was performed only in cases of suspected associated ureteral injury.

RESULTS:

We recorded 443 vaginal hysterectomies for benign disease and 95 vaginal anterior prolapse surgeries. There were 6 (1,4%) bladder injuries during vaginal hysterectomies and 1 (1,1%) bladder injury during vaginal prolapse surgery. All bladder injuries were diagnosed intraoperatively. No ureteral injury was diagnosed in this series of patients. No complication related to IV indigo carmine injection was found. In this tertiary hospital, 1085 ampoules of carmine indigo were ordered during the same period, approximatively 270 per year. The total cost to the gynecology and obstetrics department was 19,600 euros, or about 4,900 euros per year. Half of the carmine indigo was used in vaginal surgery and half in laparotomy, caesarean section and endometriosis surgery for suspected bladder or ureteral injury.

2024-02-01·International journal of biological macromolecules

Interaction of food colorant indigo carmine with human and bovine serum albumins: A multispectroscopic, calorimetric, and theoretical investigation

Article

作者: Das, Arindam ; Sing, Shukdeb ; Basu, Anirban ; Jana, Gouranga

In this work we have studied the interaction of the food dye Indigo-Carmine (IndC) with the most studied model transport proteins i.e. human and bovine serum albumin (HSA & BSA). A multispectroscopic approach was used to analyze the details of the binding process. The intrinsic fluorescence of both the albumins was significantly quenched by IndC and the quenching was both static and dynamic in nature with the former being dominant. The HSA-lndC and BSA-IndC distance after complexation was determined by Förster resonance energy transfer (FRET) method which suggested efficient energy transfer from the albumins to IndC. Thermodynamics of serum protein-IndC complexation was estimated by isothermal titration calorimetry (ITC) which revealed that the binding was enthalpy driven. Circular dichroism (CD) and FTIR spectroscopy revealed that the binding of IndC induced secondary structural changes in both the serum proteins. Synchronous and 3D fluorescence spectroscopy revealed that the binding interaction caused microenvironmental changes of protein fluorophores. Molecular docking analysis suggested that hydrogen bonding and hydrophobic interactions are the major forces involved in the complexation process.

项与 Indigotindisulfonate sodium 相关的新闻（医药）

2023-09-05

·Science Daily

3D-printed 'living material' could clean up contaminated water

A 'living material,' made of a natural polymer combined with genetically engineered bacteria, could offer a sustainable and eco-friendly solution to clean pollutants from water. Researchers developed their living material using a seaweed-based polymer and bacteria that have been programmed to produce an enzyme that transforms various organic pollutants into harmless compounds. In tests, heir material decontaminated water solutions tainted with a pollutant from textile manufacturing: indigo carmine, a blue dye that is used to color denim. Researchers at the University of California San Diego have developed a new type of material that could offer a sustainable and eco-friendly solution to clean pollutants from water. Dubbed an "engineered living material," it is a 3D-printed structure made of a seaweed-based polymer combined with bacteria that have been genetically engineered to produce an enzyme that transforms various organic pollutants into benign molecules. The bacteria were also engineered to self-destruct in the presence of a molecule called theophylline, which is often found in tea and chocolate. This offers a way to eliminate them after they have done their job. The researchers describe the new decontaminating material in a paper published in the journal Nature Communications. "What's innovative is the pairing of a polymer material with a biological system to create a living material that can function and respond to stimuli in ways that regular synthetic materials cannot," said Jon Pokorski, a professor of nanoengineering at UC San Diego who co-led the research. The work was a collaboration among engineers, materials scientists and biologists at the UC San Diego Materials Research Science and Engineering Center (MRSEC). Co-principal investigators of the multidisciplinary team include molecular biology professors Susan Golden and James Golden and nanoengineering professor Shaochen Chen. "This collaboration allowed us to apply our knowledge of the genetics and physiology of cyanobacteria to create a living material," said Susan Golden, a faculty member in the School of Biological Sciences. "Now we can think creatively about engineering novel functions into cyanobacteria to make more useful products." To create the living material in this study, the researchers used alginate, a natural polymer derived from seaweed, hydrated it to make a gel and mixed it with a type of water-dwelling, photosynthetic bacteria known as cyanobacteria. The mixture was fed into a 3D printer. After testing various 3D-printed geometries for their material, the researchers found that a grid-like structure was optimal for keeping the bacteria alive. The chosen shape has a high surface area to volume ratio, which places most of the cyanobacteria near the material's surface to access nutrients, gases and light. The increased surface area also makes the material more effective at decontamination. As a proof-of-concept experiment, the researchers genetically engineered the cyanobacteria in their material to continually produce a decontaminating enzyme called laccase. Studies have shown that laccase can be used to neutralize a variety of organic pollutants including bisphenol A (BPA), antibiotics, pharmaceutical drugs and dyes. In this study, the researchers demonstrated that their material can be used to decontaminate the dye-based pollutant indigo carmine, which is a blue dye that is widely used in the textile industry to color denim. In tests, the material decolorized a water solution containing the dye. The researchers also developed a way to eliminate the cyanobacteria after the pollutants have been cleared. They genetically engineered the bacteria to respond to a molecule called theophylline. The molecule triggers the bacteria to produce a protein that destroys their cells. "The living material can act on the pollutant of interest, then a small molecule can be added afterwards to kill the bacteria," said Pokorski. "This way, we can alleviate any concerns about having genetically modified bacteria lingering in the environment." A preferable solution, the researchers note, is to have the bacteria destroy themselves without the addition of chemicals. This will be one of the future directions of this research. "Our goal is to make materials that respond to stimuli that are already present in the environment," said Pokorski. "We're excited about the possibilities that this work can lead to, the exciting new materials we can create. This is the kind of research that can result when researchers with cross-disciplinary expertise in materials and biological sciences join forces. This is all made possible thanks to our interdisciplinary research group at the UC San Diego MRSEC." Paper title: "Phenotypically Complex Living Materials Containing Engineered Cyanobacteria." Co-authors include Debika Datta*, Elliot L. Weiss*, Daniel Wangpraseurt, Erica Hild, Shaochen Chen, James W. Golden, Susan S. Golden and Jonathan K. Pokorski, all at UC San Diego. *These authors contributed equally to this work. This work was supported in part by the UC San Diego Materials Research Science and Engineering Center (UC San Diego MRSEC) and the National Science Foundation (DMR-2011924).

2022-07-28

·PRNewswire

Provepharm announces that it has received FDA approval for BLUDIGOTM (Indigotindisulfonate Sodium, USP) Injection.

BLUDIGOTM is the first and only indigotindisulfonate sodium injection, USP, drug product approved by the FDA. MARSEILLE, France and COLLEGEVILLE, Pa., July 12, 2022 /PRNewswire/ -- Provepharm, a French company with operations in the United States of America, specializing in the development of pharmaceutical applications, today announced that it has received FDA New Drug Approval for the marketing of its injectable BLUDIGO™ (Indigotindisulfonate Sodium) Injection . BLUDIGO™ is a diagnostic dye indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures. Provepharm filed its application for approval with the FDA in September 2021 and with this new approval, its US affiliate, Provepharm Inc., will market the product directly in the United States of America. Frederick Girard, Provepharm's Chief Medical Officer, said: "BLUDIGOTM is the second product to be granted market authorization by the FDA from Provepharm's R&D group. This new success validates Provepharm's strategy based on a high level of investment in research and development aimed at improving patients' lives and health care professionals' work on a daily basis". In addition, Mary Jane Helenek, Executive VP and COO of Provepharm, Inc., said: "Provepharm is immensely proud of this accomplishment and approval by the FDA. We will soon make this important product available to clinicians in the US." Eighty-two percent of ureter injuries occur during pelvic surgery, and 75% of urinary tract injuries are due to gynecologic surgery [1]. Current estimates of urinary tract injury incidence with all types of gynecologic surgery range from 0.2 to 15 per 1,000 cases [2]. If the damage is not identified during the surgical procedure, it may lead to severe post-surgical complications, notably obstruction fistulae and sepsis, with potential impact on the functional prognosis of the kidney and sometimes on the vital prognosis. These complications lead also to the need for reintervention, sometimes in an emergency. Hence, screening for potential iatrogenic ureteral damage during the initial procedure can provide the surgeons with an opportunity of repairing the damage immediately, which may significantly contribute to the reduction of post-surgical complications. BLUDIGO™ (Indigotindisulfonate Sodium Injection, USP) INDICATION AND IMPORTANT SAFETY INFORMATION INDICATION AND USAGE BLUDIGO™ is a diagnostic dye indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures. CONTRAINDICATIONS BLUDIGO™ is contraindicated in patients with known hypersensitivity to indigotindisulfonate or any of its components. WARNINGS AND PRECAUTIONS Cardiovascular Reactions: Severe or life-threatening cardiovascular reactions including cardiac arrest, arrhythmia, asystole, atrioventricular block second degree, hypotension, elevation in blood pressure, bradycardia, and tachycardia have been reported. Closely monitor blood pressure and cardiac rhythm during and following the BLUDIGO™ injection. Interrupt administration if reactions are observed. Hypersensitivity Reactions: Serious anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, or erythema have been reported. Monitor patients for anaphylactic reactions and have emergency equipment and trained personnel readily available. Interference with Oximetry Measurements: Anesthesiologists should be aware of the potential for artifactual reduction in SpO2 when anesthetized patients are administered BLUDIGO™. USE IN SPECIFIC POPULATIONS Renal Impairment: BLUDIGO™ is not recommended for use in patients with eGFR<30 mL/min. Pediatric Use: The safety and effectiveness of BLUDIGO™ have not been established in pediatric patients. Pregnancy and Lactation: Please consult the Full Prescribing Information before using BLUDIGO™ in a patient that is lactating, pregnant, or may be pregnant. RECOMMENDED DOSAGE The recommended dose for BLUDIGO™ is 5 mL given intravenously over 1 minute. IMPORTANT ADMINISTRATION INSTRUCTIONS Monitor blood pressure and cardiac rhythm during and following the injection. Use immediately after opening ampoule. Withdraw the contents of the ampoule through a 5 micron or smaller filter straw/filter needle to ensure that the withdrawn solution contains no particulates. The withdrawn solution should be inspected visually for particulate matter and discoloration prior to administration. Do not administer with infusion assemblies used with other diluents or drugs. Discard any unused portion. ADVERSE REACTIONS Clinical Trial Experience: The most common adverse reactions (≥ 1%) associated with BLUDIGO™ in clinical trials were: constipation, nausea, vomiting, abdominal pain, pyrexia, ALT increase, and dysuria. Postmarketing Experience: The following adverse reactions have been identified following the use of indigotindisulfonate sodium injection products: Cardiovascular disorders: cardiac arrest, arrhythmia, asystole, atrioventricular block second degree, hypotension, elevation in blood pressure, bradycardia, tachycardia General disorders and administration site conditions: injection site discoloration Immune system disorders: anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, erythema Please see the full Prescribing Information for additional important safety information. To report SUSPECTED ADVERSE REACTIONS, contact PROVEPHARM Inc. at 1–833-727-6556 or FDA at 1-800-FDA-1088 or . About Provepharm Provepharm Life Solutions is a privately held, global pharmaceutical company based in Marseille, France, specializing in molecule revitalization. Its long-standing expertise in fine chemistry and high investment in R&D allows it to improve the purity of active pharmaceutical ingredients to the highest standards for the development of drug products and medical devices. Provepharm's strategy has already proven successful through the patented development and approval of Provayblue® (methylene blue injection, USP) notably in the European Union and the United States of America. For more information, please visit References: Lee, J.S., Urologic Complications Following Obstetric and Gynecologic Surgery, Korean J Urol 2012;53:795-799, AAGL Advancing minimally invasive gynecology worldwide. AAGL Practice Report: Practice Guidelines for Intraoperative Cystoscopy in Laparoscopic Hysterectomy. Journal of Minimally Invasive Gynecology 2012; 19(4): 407-411 Media Contact Theresa Brogdon (610) 601-8600 [email protected] SOURCE Provepharm Inc.

药物审批

100 项与 Indigotindisulfonate sodium 相关的药物交易

登录后查看更多信息

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
诊断试剂	日本	Daiichi Sankyo Co., Ltd.	1950-09-01

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
输尿管疾病	临床3期	-	Provepharm Life Solutions SA	2024-06-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Pubmed \| Am J Gastroenterol	N/A	遗传性非息肉病性结直肠癌	138	Indigo Carmine (Narrow-band imaging (NBI))	餘願廠艱網鹽糧願壓鏇(觸壓鏇鑰鹹築製鬱衊製) = 範範鹽艱築膚繭遞糧醖鑰願襯醖網廠鑰鹽鬱鏇 (繭範網鑰鑰淵獵鏇遞膚 ) 更多	-	2019-10-01
NCT01607255 (CTgov)	临床4期	腺瘤 \| 结直肠癌	480	water (exchange) method (Water (Exchange) Method)	範鏇顧鏇鏇願繭願鏇繭(淵網獵鹹襯網壓夢壓簾) = 蓋築醖範獵鬱範獵憲選壓築築繭鹹衊觸繭繭範 (願鹽廠餘窪鹽壓繭憲繭, 膚糧遞網鬱築獵繭夢遞 ~ 窪繭遞構膚選積憲窪鑰) 更多	-	2019-01-15
NCT01607255 (CTgov)	临床4期	腺瘤 \| 结直肠癌	480	water (exchange) plus dye method+Indigo carmine (Water (Exchange) Plus Dye Method)	範鏇顧鏇鏇願繭願鏇繭(淵網獵鹹襯網壓夢壓簾) = 獵廠齋築積憲餘鏇鹹衊壓築築繭鹹衊觸繭繭範 (願鹽廠餘窪鹽壓繭憲繭, 夢製艱觸網憲窪鑰繭憲 ~ 願憲鏇衊觸製窪衊製憲) 更多	-	2019-01-15
NCT01767415 (CTgov)	临床1/2期	脑癌	10	Indigo carmine	糧艱廠範窪蓋齋鹽鑰網(廠築構範願獵膚衊膚鏇) = 遞觸積網醖壓齋繭窪膚衊廠鏇願選簾衊積鏇獵 (襯製壓構衊顧選衊餘餘, 膚淵範積鏇窪蓋醖艱構 ~ 鏇鏇衊鑰觸淵衊製選觸) 更多	-	2018-12-11