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NCT05954767 · ClinicalTrials.gov registry record · Phase 3
IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery
A Phase 3 study of Ureter Injury, sponsored by Intuitive Surgical.
- Completed
- Registry status
- Phase 3
- Development phase
- 189
- Enrollment target
- 8
- Study locations
NCT05954767: Completed Phase 3 study of Ureter Injury, sponsored by Intuitive Surgical.
NCT05954767 is a Phase 3 study of Ureter Injury that has completed, run by Intuitive Surgical. The registered enrollment target is 189 participants, above the 78-participant average among 5 other Ureter Injury trials with a reported enrollment target (142% higher). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05954767, a Phase 3 study of Ureter Injury, has completed, sponsored by Intuitive Surgical.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 189 participants
- Enrollment target
- 8
- Study locations
Study Summary
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation.
Primary Outcome
Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 10 minutes after IS-001 injection
Conditions Studied
Interventions
- DRUG IS-001
Study Locations (8)
Florida
- HCA Mercy Hospital - Miami
- Orlando Health - Orlando
Ohio
- The Ohio State Unversity - Columbus
- OhioHealth - Columbus
California
- Hoag Memorial Hospital Presbyterian - Newport Beach
Michigan
- E.W. Sparrow Hospital - Lansing
Nevada
- MountainView Hospital - Las Vegas
Texas
- St. David's Surgical Hospital - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 189 participants |
| Start Date | 2024-01-17 |
| Est. Completion | 2025-09-29 |
| Phase | Phase 3 |
What the finished NCT05954767 record still lists
NCT05954767 is an interventional study that assigns participants to a tested intervention. The registered 189 participants enrollment target is mid-sized for trials with a published cap, above the 78-participant average among 5 other Ureter Injury trials with a reported enrollment target (142% higher).
The record links to 1 condition, with Ureter Injury appearing as the primary indexed condition, and to 1 intervention - of which IS-001 is the first listed.
NCT05954767 lists 8 locations in 6 states (Florida, Ohio, California).
Frequently Asked Questions
What is clinical trial NCT05954767 about?
NCT05954767 is a clinical study titled "IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery". This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation.
What is the current status of trial NCT05954767?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 189 participants. The study started on 2024-01-17. Estimated completion is 2025-09-29.
What conditions does trial NCT05954767 study?
This clinical trial studies the following conditions: Ureter Injury.
What interventions are being tested in trial NCT05954767?
The interventions under investigation include: IS-001 (DRUG).
Who is sponsoring clinical trial NCT05954767?
This trial is sponsored by Intuitive Surgical, which has 40 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05954767 being conducted?
This trial has 8 study locations across California, Florida, Michigan, Nevada, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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