Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06054880
PHASE4

Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency

Sponsor: Prove pharm

View on ClinicalTrials.gov

Summary

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 when used as an aid in the determination of ureteral patency.

Official title: An Open-Label, Randomized, Multicenter Study to Evaluate the Safety, Efficacy, and Physician Satisfaction of Two Different Doses of Bludigo™ When Used as an Aid in the Determination of Ureteral Patency

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

116

Start Date

2023-10-12

Completion Date

2026-02-28

Last Updated

2026-01-22

Healthy Volunteers

No

Conditions

Interventions

DRUG

Indigotindisulfonate sodium 0.8%

Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice.

OTHER

Saline injection 0.9%

Placebo

Locations (1)

Albany Medical Center

Albany, New York, United States