Using Bludigo™ to assess ureteral patency during surgery
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
This study is testing two different doses of Bludigo™ to see if it helps doctors check if the ureters are clear during surgery for people aged 18 to 85.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Prove pharm Industry-sponsored |
| Locations | 1 site (Albany, New York) |
| Trial ID | NCT06054880 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of two different doses of Bludigo™ (indigotindisulfonate Sodium Injection, USP) in determining ureteral patency during surgical procedures. It is a randomized, multicenter study involving subjects aged 18 to 85 who are scheduled for surgery requiring cystoscopy to assess ureter function. Participants will undergo screening to ensure eligibility, including medical history and baseline testing, before being randomized to receive either the drug or a saline injection. The study aims to provide insights into the optimal dosage for effective ureter assessment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 scheduled for surgery where ureteral patency needs to be evaluated.
Not a fit: Patients with severe chronic kidney failure or those with known hypersensitivity to Bludigo™ or similar dyes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes by providing a reliable method for assessing ureteral patency.
How similar studies have performed: While similar approaches have been explored, the specific use of Bludigo™ for this purpose is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects between ≥ 18 and ≤ 85 years old * Subjects who signed a written IRB approved, informed consent form * Subjects scheduled for a surgical procedure in which the patency of the ureter must be assessed by cystoscopy following the procedure Exclusion Criteria: * Subjects with stage 4 or 5 Chronic Kidney Failure as evidenced by a GFR \<30 mL/min (calculated using the MDRD formula and standardized by using individual's body surface area) or need for dialysis in the near future, or having only 1 kidney * Subjects with known severe hypersensitivity reactions to Bludigo™ or other dyes, including contrast dyes * Known history of drug or alcohol abuse within 6 months prior to the time of screening visit * Subjects, as assessed by the Investigator, with conditions/concomitant diseases precluding their safe participation in this study (e.g. major systemic diseases) * Unable to meet specific protocol requirements (e.g., scheduled visits) or subject is uncooperative or has a condition that could lead to non-compliance with the study procedures * Subject is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol * Subjects with life expectancy \< 6 months * Requirement for concomitant treatment that could bias primary evaluation. * Subjects who are pregnant or breast-feeding
Where this trial is running
Albany, New York
- Albany Medical Center — Albany, New York, United States (Recruiting)
Study contacts
- Study coordinator: Michelle Boytim, Ph.D.
- Email: michelle.boytim@provepharm.com
- Phone: 610-850-7115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.