Digestive Health Clinical Trials
IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery
Learn MoreWhat is the purpose of this study?
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation
Eligibility
- Male and female participants between the ages of 16 and 75, inclusive
- Participant is scheduled to undergo robotic-assisted colectomy using the da Vinci X/Xi Surgical System with SFF Fluorescence Imaging
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
- Aspartate aminotransferase (AST) ≥ 2.5 × ULN
- Alanine aminotransferase (ALT) ≥ 2.5 × ULN
- 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.
Where can I participate?
More about this Clinical TrialWhat is the full name of this Clinical Trial?
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
- Disease Type/ConditionUreter Injury
- Principal InvestigatorBabak N. Rad, MD
- Co-InvestigatorsEunseo Kim, PA
- Age GroupChild, Adult, Older Adult
- PhaseIII
- ClinicalTrials.gov IDNCT07346066
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Laurie Hendricks, MSN, RN, OCN
laurie.hendricks@hoag.org
Hoag Digestive Health Institute
Hoag Digestive Health Institute provides advanced, comprehensive care for the full spectrum of digestive conditions, with access to world-class specialists, diagnostics and imaging, advanced interventional therapeutics, and clinical trials. Patients benefit from a research-driven approach that connects leading-edge treatment options with personalized care across gastroenterology and GI surgery.
Stay up-to-date on the latest news from Hoag
By submitting this request, you agree to receive communications from Hoag and accept our Privacy Policy and Terms of Use.