CompletedPhase 3

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

United States189 participantsStarted 2024-01-17

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

SexFEMALE

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Inclusion criteria

✓. Female subject is between the ages of 16 and 75, inclusive at time of consent.
✓. Subject is scheduled to undergo robotic-assisted gynecological procedure using a da Vinci® Surgical System with Firefly® Fluorescence Imaging.
✓. Subject and/or subject's parent/guardian is willing and able to provide informed consent and/or assent as applicable.

Exclusion criteria

✕. Subject is pregnant or nursing.
✕. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
✕. Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months
✕. Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile
✕. Subject has a known or suspected hypersensitivity to indocyanine green (ICG)
✕. Subject has any of the following screening laboratory values:
✕. eGFR \< 60 mL/min/1.73 m\^2
✕. Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) ≥ 2.5 × ULN

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

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: 30 minutes

Trial details

NCT IDNCT05954767

SponsorIntuitive Surgical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-31

View on ClinicalTrials.gov More Ureter Injury trials