Injection to improve ureter visibility during robotic gynecological surgery

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

This study is testing an injection to see if it can help doctors see the ureters better during robotic gynecological surgeries to prevent injuries.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 237 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Intuitive Surgical (industry)
• Locations: 9 sites (Newport Beach, California and 8 other locations)
• Trial ID: NCT05954767 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of IS-001, an intravenous injection, to enhance the visualization of the ureter during robotic-assisted gynecological surgeries. Ureter injuries are serious complications that can occur during pelvic and abdominal surgeries, often going unnoticed. By using the da Vinci® Surgical System and Firefly® imaging, this study aims to improve surgical outcomes by providing better delineation of the ureter structure. The trial will involve female patients scheduled for these procedures and will assess the impact of IS-001 on intraoperative ureter identification.

Who should consider this trial

Good fit: Ideal candidates are females aged 18 to 75 who are scheduled for robotic-assisted gynecological procedures using the da Vinci® system.

Not a fit: Patients who are pregnant, nursing, or have certain medical conditions such as active hepatitis infections or hypersensitivity to indocyanine green may not benefit from this study.

Why it matters

Potential benefit: If successful, this could significantly reduce the incidence of ureter injuries during robotic-assisted surgeries, leading to better patient outcomes.

How similar studies have performed: While the approach of using IS-001 for ureter visualization is innovative, similar studies have shown promise in enhancing surgical outcomes through improved imaging techniques.

Eligibility criteria

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 Vinci® surgical system with Firefly® 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) ≥ 2.5 × upper limit normal (ULN)
   3. Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 2.5 × upper limit normal (ULN).

Where this trial is running

Newport Beach, California and 8 other locations

• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (RECRUITING)
• HCA Mercy Hospital — Miami, Florida, United States (RECRUITING)
• Orlando Health — Orlando, Florida, United States (RECRUITING)
• E.W. Sparrow Hospital — Lansing, Michigan, United States (ACTIVE_NOT_RECRUITING)
• MountainView Hospital — Las Vegas, Nevada, United States (RECRUITING)
• The Ohio State Unversity — Columbus, Ohio, United States (RECRUITING)
• OhioHealth — Columbus, Ohio, United States (RECRUITING)
• St. David's Surgical Hospital — Austin, Texas, United States (RECRUITING)
• The Hospital of Providence Transmountain Campus — El Paso, Texas, United States (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Karen Hwang

Conditions: Ureter Injury