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2025-01-01

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

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100 项与 Indigotindisulfonate sodium 相关的转化医学

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100 项与 Indigotindisulfonate sodium 相关的专利（医药）

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608

项与 Indigotindisulfonate sodium 相关的文献（医药）

2025-04-01·DEN open

Recent advancements in image‐enhanced endoscopy in the pancreatobiliary field

Review

作者: Toyonaga, Haruka ; Hayashi, Tsuyoshi ; Takahashi, Kuniyuki ; Ishii, Tatsuya ; Kin, Toshifumi ; Yoshida, Kenta ; Motoya, Masayo ; Katanuma, Akio ; Ando, Ryo ; Hama, Kazuki

Abstract:

Image‐enhanced endoscopy (IEE) has advanced gastrointestinal disease diagnosis and treatment. Traditional white‐light imaging has limitations in detecting all gastrointestinal diseases, prompting the development of IEE. In this review, we explore the utility of IEE, including texture and color enhancement imaging and red dichromatic imaging, in pancreatobiliary (PB) diseases. IEE includes methods such as chromoendoscopy, optical‐digital, and digital methods. Chromoendoscopy, using dyes such as indigo carmine, aids in delineating lesions and structures, including pancreato‐/cholangio‐jejunal anastomoses. Optical‐digital methods such as narrow‐band imaging enhance mucosal details and vessel patterns, aiding in ampullary tumor evaluation and peroral cholangioscopy. Moreover, red dichromatic imaging with its specific color allocation, improves the visibility of thick blood vessels in deeper tissues and enhances bleeding points with different colors and see‐through effects, proving beneficial in managing bleeding complications post‐endoscopic sphincterotomy. Color enhancement imaging, a novel digital method, enhances tissue texture, brightness, and color, improving visualization of PB structures, such as PB orifices, anastomotic sites, ampullary tumors, and intraductal PB lesions. Advancements in IEE hold substantial potential in improving the accuracy of PB disease diagnosis and treatment. These innovative techniques offer advantages paving the way for enhanced clinical management of PB diseases. Further research is warranted to establish their standard clinical utility and explore new frontiers in PB disease management.

2025-01-01·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Spectral characterization of micellar-enhanced fluorescence of europium (III)-doxycycline complex and its employment as a sensor for development of a highly sensitive fluorimetric assay for determination of indigo carmine in real syrups

Article

作者: Abdel-Lateef, Mohamed A. ; Darwish, Ibrahim A ; Zhang, Daohong ; Abdel-Lateef, Mohamed A ; Darwish, Ibrahim A.

Indigo carmine (IN-CR) is a synthetic blue dye widely used as a coloring agent in various food and beverage products. It is recognized for its ability to enhance the visual appeal, hue, and consistency of food products. However, recent studies have raised concerns about the potential health risks associated with this substance. Therefore, a highly sensitive analytical tool is required for the trace determination of IN-CR in food products. This study describes the spectral characteristics of micellar-enhanced fluorescence of europium (III)-doxycycline complex and its employment as a sensor for the development of a highly sensitive fluorimetric assay for the trace determination of IN-CR. The complex was formed in an alkaline medium containing hydrogen peroxide and encapsulated into cetyltrimethylammonium bromide micelles. This micellar-encapsulated complex exhibited significantly enhanced fluorescence at a wavelength of 613.5 nm, overlapping with the maximum absorption peak of IN-CR at 610 nm. This inner-filter effect phenomenon resulted in IN-CR's concentration-dependent quenching of the complex's fluorescence. The fluorescence quenching of the complex by inner-filter effect of IN-CR was adopted in the development of a highly sensitive fluorimetric assay for IN-CR. The conditions of the assay were refined, and the optimum procedures were established. The assay was validated for its performance characteristics, and all the validation criteria were met. The assay displayed linearity within the IN-CR concentration range of 100-1250 ng mL^-1, with a limit of detection at 41.2 ng mL^-1. Importantly, the assay exhibited no interference from other substances commonly used as food additives. The recoveries ranged from 99.11 % to 101.57 %, with relative standard deviations ranging from 1.34 % to 1.89 %.The assay was successfully applied to the determination of IN-CR in commercial syrup products, and the recoveries ranged from 93.5 % to 106.32 % with relative standard deviations ≤4.72 %, confirming the reliability of the assay. The proposed assay provides some key advantages, including a novel application of the europium (III)-doxycycline complex as a fluorescence sensor for the determination of IN-CR in real syrups innovative, high sensitivity and selectivity, simplicity of analysis procedures, time-saving of entire analysis protocol. In conclusion, the assay serves as a valuable tool for quantifying IN-CR in food products, facilitating the assessment of both food quality and safety.

2025-01-01·Urogynecology (Philadelphia, Pa.)

At the Scrub Sink: Evaluation of Ureteric Patency During Cystoscopy

Article

作者: El-Nashar, Sherif A

Abstract:

At the scrub sink, we discussed the best ways to evaluate for ureteric patency during cystoscopy. For decades, surgeons have been using intravenous indigo carmine for evaluating ureteric patency. Ten years ago, a shortage of indigo carmine halted production. In response to the shortage of indigo carmine, surgeons went into action, developing alternative strategies that are evidence-based and cost-effective. The shortage is over now; the lessons we learned as a subspeciality can help us address the next challenge.

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.

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100 项与 Indigotindisulfonate sodium 相关的药物交易

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适应症	国家/地区	公司	日期
乳腺癌	日本	Daiichi Sankyo Co., Ltd.	1950-09-01
诊断试剂	日本	Daiichi Sankyo Co., Ltd.	1950-09-01
肾脏疾病	日本	Daiichi Sankyo Co., Ltd.	1950-09-01
黑色素瘤	日本	Daiichi Sankyo Co., Ltd.	1950-09-01

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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	2025-01-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


UEGW2024	N/A	腺瘤	-	INDIGOCARMINE (Endocuff vision)	繭窪憲範積醖憲淵鏇壓(糧餘顧範獵觸築膚鑰蓋) = 壓顧憲網獵顧糧廠鹹糧顧夢觸鬱鑰蓋選餘鹽鏇 (獵顧選壓夢蓋糧淵膚顧, 54 ~ 38) 更多	-	2024-10-13
UEGW2024	N/A	腺瘤	-	INDIGOCARMINE (Indigo carmine)	繭窪憲範積醖憲淵鏇壓(糧餘顧範獵觸築膚鑰蓋) = 衊淵齋選憲鏇糧簾積窪顧夢觸鬱鑰蓋選餘鹽鏇 (獵顧選壓夢蓋糧淵膚顧, 60 ~ 44) 更多	-	2024-10-13
UEGW2023	N/A	十二指肠肿瘤	-	Indigocarmine (ICME-TXI)	壓憲憲衊鏇膚蓋積範範(繭簾衊顧簾襯鹽構糧蓋) = 鹹壓壓網窪獵夢範齋夢構繭簾壓蓋衊餘構鹹繭 (齋襯蓋觸襯選網鹽糧鏇 ) 更多	-	2023-10-15
NCT01607255 (CTgov)	临床4期	腺瘤 \| 结直肠癌	480	water (exchange) method (Water (Exchange) Method)	網構窪膚選積顧網簾鬱(餘構願鏇製艱繭衊醖願) = 憲艱積鏇壓遞齋壓網衊醖憲繭積膚網鹹夢選窪 (遞齋窪齋鏇繭鹹鹹膚製, 範願餘觸鬱齋獵願選範 ~ 衊鏇蓋築衊範醖廠齋獵) 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)	網構窪膚選積顧網簾鬱(餘構願鏇製艱繭衊醖願) = 鹹醖糧選衊鹹淵膚醖構醖憲繭積膚網鹹夢選窪 (遞齋窪齋鏇繭鹹鹹膚製, 觸艱積膚憲壓淵鹹築醖 ~ 鹽蓋襯廠觸願獵壓糧願) 更多	-	2019-01-15
NCT01767415 (CTgov)	临床1/2期	脑癌	10	Indigo carmine	鹽膚鹽淵獵艱餘製願顧(繭遞選願遞艱顧夢鏇憲) = 壓願選構膚夢襯選鏇積衊鏇淵積選壓艱願壓選 (淵網築醖窪繭憲窪鹽鏇, 顧簾艱廠廠膚選醖繭繭 ~ 壓獵襯艱願簾淵築選壓) 更多	-	2018-12-11