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

Completed · Phase 3

Conditions studied: Ureter Injury

In brief

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

Key facts

Study ID

NCT05954767

Run by

Intuitive Surgical

People needed

189

Starts

2024-01-17

Expected to finish

2025-09-29

Last updated by the study team

2026-01-15

Who can join

Age: 16 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female subject is between the ages of 16 and 75, inclusive at time of consent.
• Subject is scheduled to undergo robotic-assisted gynecological procedure using a da Vinci® Surgical System with Firefly® Fluorescence Imaging.
• Subject and/or subject's parent/guardian is willing and able to provide informed consent and/or assent as applicable.

You may not qualify if…

• Subject is pregnant or nursing.
• Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months
• Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile
• Subject has a known or suspected hypersensitivity to indocyanine green (ICG)
• Subject has any of the following screening laboratory values:
• eGFR < 60 mL/min/1.73 m\^2
• Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) ≥ 2.5 × ULN
• Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 2.5 × ULN.
• Planned use of CYTALUX™ (pafolacianine) for surgery

Where it is running

• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• HCA Mercy Hospital — Miami, Florida, United States
• Orlando Health — Orlando, Florida, United States
• E.W. Sparrow Hospital — Lansing, Michigan, United States
• MountainView Hospital — Las Vegas, Nevada, United States
• The Ohio State Unversity — Columbus, Ohio, United States
• OhioHealth — Columbus, Ohio, United States
• St. David's Surgical Hospital — Austin, Texas, United States

Full record on ClinicalTrials.gov

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