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.
Conditions:
๐Ÿฆ  Ureter Injury
๐Ÿ—“๏ธ Study Start (Actual) 17 January 2024
๐Ÿ—“๏ธ Primary Completion (Estimated) May 2025
โœ… Study Completion (Estimated) July 2025
๐Ÿ‘ฅ Enrollment (Estimated) 237
๐Ÿ”ฌ Study Type INTERVENTIONAL
๐Ÿ“Š Phase PHASE3
Locations:
๐Ÿ“ Newport Beach, California, United States
๐Ÿ“ Miami, Florida, United States
๐Ÿ“ Orlando, Florida, United States
๐Ÿ“ Lansing, Michigan, United States
๐Ÿ“ Las Vegas, Nevada, United States
๐Ÿ“ Columbus, Ohio, United States
๐Ÿ“ Columbus, Ohio, United States
๐Ÿ“ Austin, Texas, United States
๐Ÿ“ El Paso, Texas, United States

๐Ÿ“‹ Eligibility Criteria

Description

    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 da Vinciยฎ surgical system with Fireflyยฎ fluorescent imaging.
    • 3. Subject is willing and able to provide informed consent.

    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 study receiving therapeutic agents within the past 6 months
    • 4. 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.
    • 5. Subject has a known or suspected hypersensitivity to indocyanine green (ICG)
    • 6. Subject has any of the following screening laboratory values:
    • 1. Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m\^2
    • 2. Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) โ‰ฅ 2.5 ร— upper limit normal (ULN)
    • 3. Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) โ‰ฅ 2.5 ร— upper limit normal (ULN).
Ages Eligible for Study: 18 Years to 75 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

๐Ÿ—“๏ธ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 1 June 2023
  • First Submitted that Met QC Criteria 13 July 2023
  • First Posted 20 July 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 May 2024
  • Last Update Posted 29 May 2024
  • Last Verified May 2024