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NCT04574401 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy
A Phase 1 study of Prostate Cancer, sponsored by Intuitive Surgical.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04574401: Completed Phase 1 study of Prostate Cancer, sponsored by Intuitive Surgical.
NCT04574401 is a Phase 1 study of Prostate Cancer that has completed, run by Intuitive Surgical. The registered enrollment target is 24 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04574401, a Phase 1 study of Prostate Cancer, has completed, sponsored by Intuitive Surgical.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1, single-site, interventional clinical trial evaluating the safety and efficacy of IS-002 intravenous (IV) injection for fluorescent identification and delineation of the positive cancer margins and metastatic lymph nodes during prostatectomy surgery using the da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging.
Primary Outcome
Number of participants treated with IS-002 with treatment-emergent adverse events as assessed by CTCAE v5.0
Conditions Studied
Interventions
- DRUG IS-002
Study Locations (1)
California
- UCSF Medical Center, Mission Bay - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-10-10 |
| Est. Completion | 2021-09-20 |
| Phase | Phase 1 |
What the finished NCT04574401 record still lists
NCT04574401 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which IS-002 is the first listed.
NCT04574401 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04574401 about?
NCT04574401 is a clinical study titled "A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy". This is a Phase 1, single-site, interventional clinical trial evaluating the safety and efficacy of IS-002 intravenous (IV) injection for fluorescent identification and delineation of the positive cancer margins and metastatic lymph nodes during prostatectomy surgery using the da Vinci® X/Xi Surgica...
What is the current status of trial NCT04574401?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2020-10-10. Estimated completion is 2021-09-20.
What conditions does trial NCT04574401 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT04574401?
The interventions under investigation include: IS-002 (DRUG).
Who is sponsoring clinical trial NCT04574401?
This trial is sponsored by Intuitive Surgical, which has 40 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04574401 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04574401's enrollment target sits among peer trials
24 634th of 735 higher than 97 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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.
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