Not Yet RecruitingPhase 3

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

146 participantsStarted 2026-03-31

Plain-language summary

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

Who can participate

Age range16 Years – 75 Years

SexALL

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Inclusion criteria

✓. Male and female participants between the ages of 16 and 75, inclusive

Exclusion criteria

✕. 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.

What they're measuring

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.

Timeframe: 10 minutes after first injection

Trial details

NCT IDNCT07346066

SponsorIntuitive Surgical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-30

Contact for this trial

Clinical Project Manager

4085232100 info.is-001@intusurg.com

View on ClinicalTrials.gov More Ureter Injury trials