CompletedPhase 2

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

United States12 participantsStarted 2023-06-14

Plain-language summary

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

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Evaluate ureter visualization by Independent Reader

Timeframe: 10 minutes after first IS-001 injection during surgery

Evaluate ureter visualization by Independent Reader

Timeframe: 30 minutes after first IS-001 injection during surgery

Evaluate ureter visualization by Independent Reader

Timeframe: 45 minutes after first IS-001 injection during surgery

Evaluate ureter visualization by Independent Reader

Timeframe: 10 minutes after second IS-001 injection during surgery

Evaluate ureter visualization by Independent Reader

Timeframe: 30 minutes after second IS-001 injection during surgery

Evaluate ureter visualization by Independent Reader

Timeframe: 45 minutes after second IS-001 injection during surgery

Trial details

NCT IDNCT05769257

SponsorIntuitive Surgical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-18

View on ClinicalTrials.gov More Ureter Injury trials

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Evaluate ureter visualization by Independent Reader

Timeframe: 10 minutes after first IS-001 injection during surgery

Evaluate ureter visualization by Independent Reader

Timeframe: 30 minutes after first IS-001 injection during surgery

Evaluate ureter visualization by Independent Reader

Timeframe: 45 minutes after first IS-001 injection during surgery

Evaluate ureter visualization by Independent Reader

Timeframe: 10 minutes after second IS-001 injection during surgery

Evaluate ureter visualization by Independent Reader

Timeframe: 30 minutes after second IS-001 injection during surgery

Evaluate ureter visualization by Independent Reader

Timeframe: 45 minutes after second IS-001 injection during surgery