Clinical Trials in the USA / NCT07346066
Recruiting
Phase 3
IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery
NCT07346066 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Ureter Injury
Investigational drug(s) / intervention(s)
filricianine
filricianine: IV injection of IS-001 filricianine with near infrared (NIR) imaging
Study summary
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation
Eligibility
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) ≥ 2.5 × ULN
2. Alanine aminotransferase (ALT) ≥ 2.5 × 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.
Primary outcome measure(s)
- Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible. — 10 minutes after first injection
Evaluate ureter visualization by each independent reader at (a) the pelvic brim (PB) and (b) Inferior Mesenteric Artery (IMA) locations in Sensitive Firefly (SFF) mode compared to white light mode up to 30 minutes after the first IS-001 injection.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | Recruiting |
| Yale New Haven Hospital | New Haven | Connecticut | Recruiting |
| Orlando Health | Orlando | Florida | Recruiting |
| Mountain View Hospital | Las Vegas | Nevada | Recruiting |
| The Ohio State Unversity | Columbus | Ohio | Not Yet Recruiting |
| Kettering Health | Kettering | Ohio | Not Yet Recruiting |
| St David's North Austin Medical Center | Austin | Texas | Recruiting |
| HCA Houston Healthcare Medical Center | Houston | Texas | Recruiting |
| MultiCare Tacoma General Hospital | Tacoma | Washington | Not Yet Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07346066 on ClinicalTrials.gov ↗ ← All trials in the USA