CLINICAL TRIALS PROFILE FOR INDIGOTINDISULFONATE SODIUM
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All Clinical Trials for indigotindisulfonate sodium
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01767415 ↗ | Intra-operative Use of Indigo Carmine Dye for the Delineation of Ill Defined Tumor Borders Using Stereotactic Injection | Completed | Weill Medical College of Cornell University | Phase 1/Phase 2 | 2012-04-01 | The purpose of this study is to investigate whether stereotactic indigo carmine injection can safely increase the extent of tumor resection. |
| NCT02677623 ↗ | Evaluation of Ureteral Patency in the Post-indigo Carmine Era | Completed | Columbia University | Phase 4 | 2015-03-01 | Many gynecologic, urologic and pelvic reconstructive surgeries require accurate ways to identify the opening of the ureters to ensure that they are working correctly. Historically, indigo carmine, an intravenous medication that dyes the urine blue, has been used to help visualize the opening of the ureters with cystoscopy which is a camera placed inside the bladder. In June 2014, the FDA announced there was current shortage of indigo carmine. Thus, investigators need to evaluate other methods for assessing ureteral patency. Ideal alternatives are agents that are low-risk, inexpensive, provide comparable visualization, are readily available and are easy to use. Examples of such agents currently being used to evaluate the ureters, include oral pyridium, IV sodium fluorescein, and mannitol. These agents help identify the opening of the ureters by either dyeing the urine a different color such as pyridium and sodium fluorescein, or by having a different viscosity to urine such as mannitol. This study will compare three methods of evaluating ureteral patency at time of cystoscopy compared to no method: mannitol, sodium fluorescein, and pyridium. |
| NCT03065075 ↗ | Effect of Phenazopyridine on Prolapse Surgery Voiding Trials | Completed | University of Massachusetts, Worcester | Phase 3 | 2017-02-01 | To determine if phenazopyridine reduces the rate of postoperative urinary retention after pelvic organ prolapse surgery. |
| NCT06054880 ↗ | Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency | Recruiting | Prove pharm | Phase 4 | 2023-10-12 | 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. |
| NCT06085183 ↗ | Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency in Patient's With Renal Impairment | Recruiting | Prove pharm | Phase 4 | 2023-12-20 | 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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