A Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic Colorectal Surgery

Completed · Phase 2

Conditions studied: Ureter Injury

In brief

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

Key facts

Study ID: NCT05769257
Run by: Intuitive Surgical
People needed: 12
Starts: 2023-06-14
Expected to finish: 2024-04-04
Last updated by the study team: 2024-05-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male and female subjects between the ages of 18 and 75, inclusive
Subject is scheduled to undergo robotic-assisted rectal, sigmoid, or left colon resection surgery using the da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging

You may not qualify if…

Subject is pregnant or nursing
Subject has known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Subject has any of the following screening laboratory values:
eGFR < 60 mL/min/1.73 m\^2
Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase ≥ 2.5 × ULN
Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase ≥ 2.5 × ULN
Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months
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
Subjects with known or suspected hypersensitivity to indocyanine green (ICG) or any components of the formulation used.

Where it is running

St. David's North Austin Medical Center — Austin, Texas, United States
MultiCare Tacoma General Hospital — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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