Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 4

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

NCT06054880 · View on ClinicalTrials.gov ↗

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

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06054880

The ClinicalTrials.gov registry entry for NCT06054880 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Prove pharm, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06054880 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06054880?

The interventions under investigation include: Indigotindisulfonate sodium 0.8% (DRUG), Saline injection 0.9% (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06054880?

This trial is sponsored by Prove pharm, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial