IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery
ConditionUreter Injury
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age16-75
SponsorIntuitive Surgical
About this trial
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- filricianine
Treatment groups
146 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov