NCT06054880 Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency
| NCT ID | NCT06054880 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Prove pharm |
| Condition | Ureter Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2023-10-12 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 116 participants in total. It began in 2023-10-12 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Michelle Boytim, Ph.D.
STUDY DIRECTOR
Provepharm SAS
Frequently Asked Questions
Who can join the NCT06054880 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Ureter Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06054880 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06054880 currently recruiting?
Yes, NCT06054880 is actively recruiting participants. Contact the research team at michelle.boytim@provepharm.com for enrollment information.
Where is the NCT06054880 trial being conducted?
This trial is being conducted at Albany, United States.
Who is sponsoring the NCT06054880 clinical trial?
NCT06054880 is sponsored by Prove pharm. The principal investigator is Michelle Boytim, Ph.D. at Provepharm SAS. The trial plans to enroll 116 participants.