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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05954767

Public ClinicalTrials.gov record NCT05954767. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 4:36 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Multi-Center Efficacy Study of IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging

Study identification

NCT ID
NCT05954767
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Intuitive Surgical
Industry
Enrollment
189 participants

Conditions and interventions

Conditions

Interventions

  • IS-001 Drug

Drug

Eligibility (public fields only)

Age range
16 Years to 75 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 16, 2024
Primary completion
Jan 30, 2025
Completion
Sep 28, 2025
Last update posted
Jan 14, 2026

2024 – 2025

United States locations

U.S. sites
8
U.S. states
6
U.S. cities
7
Facility City State ZIP Site status
Hoag Memorial Hospital Presbyterian Newport Beach California 92663
HCA Mercy Hospital Miami Florida 33133
Orlando Health Orlando Florida 32806
E.W. Sparrow Hospital Lansing Michigan 48912
MountainView Hospital Las Vegas Nevada 89128
The Ohio State Unversity Columbus Ohio 43210
OhioHealth Columbus Ohio 43214
St. David's Surgical Hospital Austin Texas 78681

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05954767, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 14, 2026 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05954767 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →