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

Intuitive Surgical

Status and phase: Completed; Phase 3

Conditions: Ureter Injury

Treatments: Drug: IS-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT05954767

ISI-124804-3

Details and patient eligibility

About

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

Full 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.

Enrollment: 189 patients

Sex: Female

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female subject is between the ages of 16 and 75, inclusive at time of consent.
2. Subject is scheduled to undergo robotic-assisted gynecological procedure using a da Vinci® Surgical System with Firefly® Fluorescence Imaging.
3. Subject and/or subject's parent/guardian is willing and able to provide informed consent and/or assent as applicable.

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. eGFR < 60 mL/min/1.73 m^2
   2. Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) ≥ 2.5 × ULN
   3. Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 2.5 × ULN.

7. Planned use of CYTALUX™ (pafolacianine) for surgery

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

189 participants in 1 patient group

Efficacy

Other group

Description:

Single intravenous injection of IS-001 and ureter visualization and delineation will be compared in white light standard of care and near-infrared (NIR) imaging mode.

Treatment:

Drug: IS-001