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Last Updated: November 22, 2024

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CLINICAL TRIALS PROFILE FOR BLUDIGO


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All Clinical Trials for BLUDIGO

Trial ID Title Status Sponsor Phase Start Date Summary
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 >Phase >Start Date >Summary

Clinical Trial Conditions for BLUDIGO

Condition Name

Condition Name for BLUDIGO
Intervention Trials
Ureter Injury 2
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Condition MeSH

Condition MeSH for BLUDIGO
Intervention Trials
Renal Insufficiency 1
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Clinical Trial Locations for BLUDIGO

Trials by Country

Trials by Country for BLUDIGO
Location Trials
United States 2
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Trials by US State

Trials by US State for BLUDIGO
Location Trials
New York 2
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Clinical Trial Progress for BLUDIGO

Clinical Trial Phase

Clinical Trial Phase for BLUDIGO
Clinical Trial Phase Trials
Phase 4 2
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Clinical Trial Status

Clinical Trial Status for BLUDIGO
Clinical Trial Phase Trials
Recruiting 2
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Clinical Trial Sponsors for BLUDIGO

Sponsor Name

Sponsor Name for BLUDIGO
Sponsor Trials
Prove pharm 2
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Sponsor Type

Sponsor Type for BLUDIGO
Sponsor Trials
Industry 2
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