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

Last updated: May 28, 2024
Sponsor: Intuitive Surgical
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

IS-001

Clinical Study ID

NCT05954767
ISI-124804-3
  • Ages 18-75
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

Inclusion Criteria

  1. Female subject is between the ages of 18 and 75, inclusive.

  2. Subject is scheduled to undergo robotic-assisted gynecological procedure using a daVinci® surgical system with Firefly® fluorescent imaging.

  3. Subject is willing and able to provide informed consent.

Exclusion

Exclusion Criteria:

  1. Subject is pregnant or nursing.

  2. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV)infection.

  3. Subject is already enrolled in another investigational drug or device studyreceiving therapeutic agents within the past 6 months

  4. Subject has any other condition or personal circumstance that, in the judgment ofthe Investigator, might interfere with the collection of complete quality data orrepresents an unacceptable safety profile.

  5. Subject has a known or suspected hypersensitivity to indocyanine green (ICG)

  6. Subject has any of the following screening laboratory values:

  7. Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2

  8. Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) ≥ 2.5 × upper limit normal (ULN)

  9. Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 2.5 × upper limit normal (ULN).

Study Design

Total Participants: 237
Treatment Group(s): 1
Primary Treatment: IS-001
Phase: 3
Study Start date:
January 17, 2024
Estimated Completion Date:
July 31, 2025

Study Description

Injury to the ureter, the duct by which urine passes from the kidney into the bladder, is a well-known and serious complication of pelvic and abdominal surgery that frequently goes unrecognized intraoperatively. This study seeks to evaluate the safety and efficacy of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery with the da Vinci® Surgical System and Firefly® imaging.

Connect with a study center

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • HCA Mercy Hospital

    Miami, Florida 33133
    United States

    Active - Recruiting

  • Orlando Health

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • E.W. Sparrow Hospital

    Lansing, Michigan 48912
    United States

    Site Not Available

  • MountainView Hospital

    Las Vegas, Nevada 89128
    United States

    Active - Recruiting

  • OhioHealth

    Columbus, Ohio 43214
    United States

    Active - Recruiting

  • The Ohio State Unversity

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • St. David's Surgical Hospital

    Austin, Texas 78681
    United States

    Active - Recruiting

  • The Hospital of Providence Transmountain Campus

    El Paso, Texas 79911
    United States

    Site Not Available

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