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

NCT05954767 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2026-01-15

No results posted yet for this study

Summary

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

Conditions

  • Ureter Injury

Interventions

DRUG

IS-001

IV injection of IS-001 drug substance with near infrared (NIR) imaging

Sponsors & Collaborators

  • Intuitive Surgical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-17
Primary Completion
2025-01-31
Completion
2025-09-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05954767 on ClinicalTrials.gov