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 range

18 Years – 75 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years – 75 Years

Sex

ALL

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