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NCT06054880 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Ureter Injury, sponsored by Prove pharm.

Recruiting
Registry status
Phase 4
Development phase
116
Enrollment target
1
Study location

NCT06054880 is a Phase 4 study of Ureter Injury that is actively recruiting participants, run by Prove pharm. The registered enrollment target is 116 participants, above the 92-participant average among 5 other Ureter Injury trials with a reported enrollment target (26% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT06054880, a Phase 4 study of Ureter Injury, is actively recruiting participants, sponsored by Prove pharm.

RECRUITING
Registry status
Phase 4
Development phase
116 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • DRUG Indigotindisulfonate sodium 0.8%
  • OTHER Saline injection 0.9%

Study Locations (1)

New York

  • Albany Medical Center - Albany

Trial Details

FieldValue
Enrollment Target 116 participants
Start Date 2023-10-12
Est. Completion 2026-02-28
Phase Phase 4

Sponsor

Prove pharm

3 total trials

What the Registry Record Tells You About NCT06054880

The ClinicalTrials.gov registry entry for NCT06054880 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 92-participant average among 5 other Ureter Injury trials with a reported enrollment target (26% higher). 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 Indigotindisulfonate sodium 0.8% is the first listed.

NCT06054880 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT06054880 about?

NCT06054880 is a clinical study titled "Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency". 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.

What is the current status of trial NCT06054880?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 116 participants. The study started on 2023-10-12. Estimated completion is 2026-02-28.

What conditions does trial NCT06054880 study?

This clinical trial studies the following conditions: Ureter Injury.

What interventions are being tested in trial NCT06054880?

The interventions under investigation include: Indigotindisulfonate sodium 0.8% (DRUG), Saline injection 0.9% (OTHER).

Who is sponsoring clinical trial NCT06054880?

This trial is sponsored by Prove pharm, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06054880 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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