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NCT05769257 · ClinicalTrials.gov registry record · Phase 2
A Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic Colorectal Surgery
A Phase 2 study, sponsored by Intuitive Surgical.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT05769257: Completed Phase 2 study, sponsored by Intuitive Surgical.
NCT05769257 is a Phase 2 study that has completed, run by Intuitive Surgical. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05769257, a Phase 2 study, has completed, sponsored by Intuitive Surgical.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
This study evaluates the safety and feasibility of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation
Primary Outcome
Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a Five-point rating scale where 1 = Not Visible, 1 = Questionably Visible, 3 = Low Visibility, 4 = Visible, 5 = Clearly Visible
Interventions
- DRUG IS-001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2023-06-14 |
| Est. Completion | 2024-04-04 |
| Phase | Phase 2 |
What the finished NCT05769257 record still lists
NCT05769257 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which IS-001 is the first listed.
NCT05769257 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05769257 about?
NCT05769257 is a clinical study titled "A Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic Colorectal Surgery". This study evaluates the safety and feasibility of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation
What is the current status of trial NCT05769257?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2023-06-14. Estimated completion is 2024-04-04.
What interventions are being tested in trial NCT05769257?
The interventions under investigation include: IS-001 (DRUG).
Who is sponsoring clinical trial NCT05769257?
This trial is sponsored by Intuitive Surgical, which has 40 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05769257's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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