COMPLETED

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

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Conditions

Ureter Injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2024-01-17
Study Completion:2025-09-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05954767

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 75 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Female subject is between the ages of 16 and 75, inclusive at time of consent.
  2. 2. Subject is scheduled to undergo robotic-assisted gynecological procedure using a da Vinci® Surgical System with Firefly® Fluorescence Imaging.
  3. 3. Subject and/or subject's parent/guardian is willing and able to provide informed consent and/or assent as applicable.
  1. 1. Subject is pregnant or nursing.
  2. 2. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  3. 3. Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months
  4. 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. 5. Subject has a known or suspected hypersensitivity to indocyanine green (ICG)
  6. 6. Subject has any of the following screening laboratory values:
  7. 1. eGFR \< 60 mL/min/1.73 m\^2
  8. 2. Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) ≥ 2.5 × ULN
  9. 3. Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 2.5 × ULN.
  10. 7. Planned use of CYTALUX™ (pafolacianine) for surgery

Contacts and Locations

Study Locations (Sites)

Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
United States
HCA Mercy Hospital
Miami, Florida, 33133
United States
Orlando Health
Orlando, Florida, 32806
United States
E.W. Sparrow Hospital
Lansing, Michigan, 48912
United States
MountainView Hospital
Las Vegas, Nevada, 89128
United States
The Ohio State Unversity
Columbus, Ohio, 43210
United States
OhioHealth
Columbus, Ohio, 43214
United States
St. David's Surgical Hospital
Austin, Texas, 78681
United States

Collaborators and Investigators

Sponsor: Intuitive Surgical

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

Study Start Date2024-01-17
Study Completion Date2025-09-29

Study Record Updates

Study Start Date2024-01-17
Study Completion Date2025-09-29

Terms related to this study

Additional Relevant MeSH Terms

  • Ureter Injury