IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery
Public ClinicalTrials.gov record NCT05954767. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Multi-Center Efficacy Study of IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation.
Study identification
- NCT ID
- NCT05954767
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 189 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years to 75 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 17, 2024 (Actual)
- Primary completion
- Jan 31, 2025 (Actual)
- Completion
- Sep 29, 2025 (Actual)
- Last update posted
- Jan 15, 2026
2024 – 2025
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | — |
| HCA Mercy Hospital | Miami | Florida | 33133 | — |
| Orlando Health | Orlando | Florida | 32806 | — |
| E.W. Sparrow Hospital | Lansing | Michigan | 48912 | — |
| MountainView Hospital | Las Vegas | Nevada | 89128 | — |
| The Ohio State Unversity | Columbus | Ohio | 43210 | — |
| OhioHealth | Columbus | Ohio | 43214 | — |
| St. David's Surgical Hospital | Austin | Texas | 78681 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05954767, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 15, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05954767 live on ClinicalTrials.gov.