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NCT05946603 · ClinicalTrials.gov registry record · Phase 2
IS-002 Phase 2 Prostate Cancer Study
A Phase 2 study, sponsored by Intuitive Surgical.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
NCT05946603: Completed Phase 2 study, sponsored by Intuitive Surgical.
NCT05946603 is a Phase 2 study that has completed, run by Intuitive Surgical. The registered enrollment target is 59 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05946603, a Phase 2 study, has completed, sponsored by Intuitive Surgical.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
Study Summary
Phase 2 randomized controlled multi-center study of IS-002, in conjunction with near-infrared (NIR) fluorescence imaging, for identification of prostate cancer during robotic-assisted radical prostatectomy (RARP) with (extended) pelvic lymph node dissection ((e)PLND) using the da Vinci® X/Xi Surgical System with Firefly® Fluorescence Imaging.
Primary Outcome
The proportion of subjects with ≥1 PSMs on final histopathologic assessment in the Intervention arm and the Control arm.
Interventions
- DRUG Administration of IS-002
- DEVICE Firefly fluorescent imaging
- PROCEDURE robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2023-06-16 |
| Est. Completion | 2025-05-23 |
| Phase | Phase 2 |
What the finished NCT05946603 record still lists
NCT05946603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 3 interventions - of which Administration of IS-002 is the first listed.
NCT05946603 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05946603 about?
NCT05946603 is a clinical study titled "IS-002 Phase 2 Prostate Cancer Study". Phase 2 randomized controlled multi-center study of IS-002, in conjunction with near-infrared (NIR) fluorescence imaging, for identification of prostate cancer during robotic-assisted radical prostatectomy (RARP) with (extended) pelvic lymph node dissection ((e)PLND) using the da Vinci® X/Xi Surgica...
What is the current status of trial NCT05946603?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2023-06-16. Estimated completion is 2025-05-23.
What interventions are being tested in trial NCT05946603?
The interventions under investigation include: Administration of IS-002 (DRUG), Firefly fluorescent imaging (DEVICE), robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection (PROCEDURE).
Who is sponsoring clinical trial NCT05946603?
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 NCT05946603's enrollment target sits among peer trials
59 1133rd of 2000 higher than 866 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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