A Phase 3 Multi-Center Efficacy Study of Filricianine Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery Using the da Vinci Surgical System With Firefly® Fluorescence Imaging
Intuitive Surgical
Summary
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation
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 colorectal surgery with the da Vinci® Surgical System and Firefly® imaging.
Eligibility
- Age range
- 16–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male and female participants between the ages of 16 and 75, inclusive 2. Participant is scheduled to undergo robotic-assisted colectomy using the da Vinci X/Xi Surgical System with SFF Fluorescence Imaging Exclusion Criteria 1\. Participant is pregnant or nursing 2. Participant has known current acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection 3. Participant has any of the following screening laboratory values: eGFR \< 30 mL/min/1.73 m2 1. Aspartate aminotransferase (AST) ≥ 2.5 × ULN 2. Alanine aminotransferase (ALT) ≥ 2.5 × ULN 3. Total B…