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

Description

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

Conditions

Ureter Injury

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Ureter Injury
Intervention / Treatment

-

Contacts and Locations

Newport Beach

Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States, 92663

Miami

HCA Mercy Hospital, Miami, Florida, United States, 33133

Orlando

Orlando Health, Orlando, Florida, United States, 32806

Lansing

E.W. Sparrow Hospital, Lansing, Michigan, United States, 48912

Las Vegas

MountainView Hospital, Las Vegas, Nevada, United States, 89128

Columbus

The Ohio State Unversity, Columbus, Ohio, United States, 43210

Columbus

OhioHealth, Columbus, Ohio, United States, 43214

Austin

St. David's Surgical Hospital, Austin, Texas, United States, 78681

El Paso

The Hospital of Providence Transmountain Campus, El Paso, Texas, United States, 79911

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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 Vinci® surgical system with Firefly® fluorescent imaging.
  • 3. Subject is willing and able to provide informed consent.
  • 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) ≥ 2.5 × upper limit normal (ULN)
  • 3. Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 2.5 × upper limit normal (ULN).

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Intuitive Surgical,

Study Record Dates

2025-07