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NCT03937505 · ClinicalTrials.gov registry record · Phase 2
A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy
A Phase 2 study of Ureter Injury, sponsored by Intuitive Surgical.
- Completed
- Registry status
- Phase 2
- Development phase
- 94
- Enrollment target
- 3
- Study locations
NCT03937505: Completed Phase 2 study of Ureter Injury, sponsored by Intuitive Surgical.
NCT03937505 is a Phase 2 study of Ureter Injury that has completed, run by Intuitive Surgical. The registered enrollment target is 94 participants, roughly in line with the 97-participant average among 5 other Ureter Injury trials with a reported enrollment target. The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03937505, a Phase 2 study of Ureter Injury, has completed, sponsored by Intuitive Surgical.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 94 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation. Stage A of the study will determine the safe optimal dose and Stage B will determine expanded safety and efficacy for intraoperative ureter structure delineation for the identified optimal dose in study participants.
Primary Outcome
Fluorescent intensity of ureter evaluated as signal to background
Conditions Studied
Interventions
- DRUG IS-001
- DRUG No treatment
Study Locations (3)
Texas
- St.David's Medical Center - Austin
- Las Palmas Medical Center - El Paso
District of Columbia
- George Washington University Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2019-05-28 |
| Est. Completion | 2021-07-22 |
| Phase | Phase 2 |
What the finished NCT03937505 record still lists
NCT03937505 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, roughly in line with the 97-participant average among 5 other Ureter Injury trials with a reported enrollment target.
The record links to 1 condition, with Ureter Injury appearing as the primary indexed condition, and to 2 interventions - of which IS-001 is the first listed.
NCT03937505 reports a single indexed study location in Texas, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT03937505 about?
NCT03937505 is a clinical study titled "A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy". This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation. Stage A of the study will determine the safe optimal dose and Stage B will determine expanded safety and efficacy for intraoperative ureter structure delineation for...
What is the current status of trial NCT03937505?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2019-05-28. Estimated completion is 2021-07-22.
What conditions does trial NCT03937505 study?
This clinical trial studies the following conditions: Ureter Injury.
What interventions are being tested in trial NCT03937505?
The interventions under investigation include: IS-001 (DRUG), No treatment (DRUG).
Who is sponsoring clinical trial NCT03937505?
This trial is sponsored by Intuitive Surgical, which has 40 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03937505 being conducted?
This trial has 3 study locations across District of Columbia, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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