AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 3Ages 16 Years - 75 YearsAllIntuitive Surgical
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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) โ‰ฅ 2.5 ร— ULN 2. Alanine aminotransferase (ALT) โ‰ฅ 2.5 ร— ULN 3. Total Bilirubin \> 2mg/dL 4. Participant has any concomitant non-colorectal cancer 5. Participant has any circumstances that, in the judgment of the Investigator, might make them not a suitable candidate for the study 6. Participants have already been enrolled in another investigational drug or device study within the past 6 months 7. Participants with known or suspected hypersensitivity to indocyanine green (ICG) or any components of the formulation used 8. Participant is expected to receive or has received other methods for ureter identification during the surgery (e.g., ureteral stent placement, illuminated catheters, retrograde ICG injections) before the administration of IS-001 9. The duration of the surgery is expected to be less than 90 minutes as determined during preoperative planning.
๐Ÿ’Š

What it tests

  • filricianine
๐Ÿ“

Where

9 sites
Hoag Memorial Hospital Presbyterian
Newport Beach, United States
Yale New Haven Hospital
New Haven, United States
Orlando Health
Orlando, United States
Mountain View Hospital
Las Vegas, United States
The Ohio State Unversity
Columbus, United States
Kettering Health
Kettering, United States
St David's North Austin Medical Center
Austin, United States
HCA Houston Healthcare Medical Center
Houston, United States

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy