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NCT06085183 · ClinicalTrials.gov registry record · Phase 4
Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment
A Phase 4 study of Ureter Injury, sponsored by Prove pharm.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT06085183: Recruiting Phase 4 study of Ureter Injury, sponsored by Prove pharm.
NCT06085183 is a Phase 4 study of Ureter Injury that is actively recruiting participants, run by Prove pharm. The registered enrollment target is 48 participants, below the 106-participant average among 5 other Ureter Injury trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06085183, a Phase 4 study of Ureter Injury, is actively recruiting participants, sponsored by Prove pharm.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Visualization will be measured by a conspicuity scale designed to provide an objective tool applicable to the visualization of the urinary flow from the ureteral orifices when determining ureter patency. The conspicuity of the urine flow from the ureteral orifices is defined using the 5-point conspicuity score as follows: 1. = No jet observed 2. = Weak jet, little color contrast 3. = Color contrast or significant jet flow 4. = Strong jet flow with good color contrast 5. = Strong jet flow with s
Conditions Studied
Interventions
- OTHER Saline Injection 0.9%
- DRUG Indigotindisulfonate sodium 0.8%
Study Locations (1)
New York
- Albany Medical Center - Albany
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2023-12-20 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 4 |
What NCT06085183 shows while recruiting
NCT06085183 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 106-participant average among 5 other Ureter Injury trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Ureter Injury appearing as the primary indexed condition, and to 2 interventions - of which Saline Injection 0.9% is the first listed.
NCT06085183 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06085183 about?
NCT06085183 is a clinical study titled "Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment". 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.
What is the current status of trial NCT06085183?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 48 participants. The study started on 2023-12-20. Estimated completion is 2026-07-31.
What conditions does trial NCT06085183 study?
This clinical trial studies the following conditions: Ureter Injury.
What interventions are being tested in trial NCT06085183?
The interventions under investigation include: Saline Injection 0.9% (OTHER), Indigotindisulfonate sodium 0.8% (DRUG).
Who is sponsoring clinical trial NCT06085183?
This trial is sponsored by Prove pharm, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06085183 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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