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NCT05954767 · ClinicalTrials.gov registry record · Phase 3

IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery

A Phase 3 study of Ureter Injury, sponsored by Intuitive Surgical.

Completed
Registry status
Phase 3
Development phase
189
Enrollment target
8
Study locations

NCT05954767 is a Phase 3 study of Ureter Injury that has completed, run by Intuitive Surgical. The registered enrollment target is 189 participants, above the 78-participant average among 5 other Ureter Injury trials with a reported enrollment target (142% higher). The trial reports 8 study locations across 6 states.

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The verdict

NCT05954767, a Phase 3 study of Ureter Injury, has completed, sponsored by Intuitive Surgical.

COMPLETED
Registry status
Phase 3
Development phase
189 participants
Enrollment target
8
Study locations

Study Summary

This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation.

Conditions Studied

Ureter Injury

Interventions

  • DRUG IS-001

Study Locations (8)

Florida

  • HCA Mercy Hospital - Miami
  • Orlando Health - Orlando

Ohio

  • The Ohio State Unversity - Columbus
  • OhioHealth - Columbus

California

  • Hoag Memorial Hospital Presbyterian - Newport Beach

Michigan

  • E.W. Sparrow Hospital - Lansing

Nevada

  • MountainView Hospital - Las Vegas

Texas

  • St. David's Surgical Hospital - Austin

Trial Details

FieldValue
Enrollment Target 189 participants
Start Date 2024-01-17
Est. Completion 2025-09-29
Phase Phase 3

Sponsor

Intuitive Surgical

40 total trials

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What the Registry Record Tells You About NCT05954767

The ClinicalTrials.gov registry entry for NCT05954767 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 189 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 78-participant average among 5 other Ureter Injury trials with a reported enrollment target (142% higher). The listed sponsor is Intuitive Surgical, which has 40 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Ureter Injury appearing as the primary indexed condition, and to 1 intervention - of which IS-001 is the first listed.

NCT05954767 reports 8 study locations spanning 6 distinct geographic areas - top geographies include Florida, Ohio, California.

Frequently Asked Questions

What is clinical trial NCT05954767 about?

NCT05954767 is a clinical study titled "IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery". This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation.

What is the current status of trial NCT05954767?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 189 participants. The study started on 2024-01-17. Estimated completion is 2025-09-29.

What conditions does trial NCT05954767 study?

This clinical trial studies the following conditions: Ureter Injury.

What interventions are being tested in trial NCT05954767?

The interventions under investigation include: IS-001 (DRUG).

Who is sponsoring clinical trial NCT05954767?

This trial is sponsored by Intuitive Surgical, which has 40 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05954767 being conducted?

This trial has 8 study locations across California, Florida, Michigan, Nevada, Ohio. 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

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.