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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06085183
The ClinicalTrials.gov registry entry for NCT06085183 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 106-participant average among 5 other Ureter Injury trials with a reported enrollment target (55% lower). The listed sponsor is Prove pharm, which has 3 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.