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NCT03998657 · ClinicalTrials.gov registry record · NA
Continued Access of Focal MR-Guided Focused Ultrasound for Localized Intermediate Risk Prostate Lesions
A NA study of Prostate Cancer, sponsored by InSightec.
- Active
- Registry status
- NA
- Development phase
- 14
- Enrollment target
- 5
- Study locations
NCT03998657: Active NA study of Prostate Cancer, sponsored by InSightec.
NCT03998657 is a NA study of Prostate Cancer that is active but no longer recruiting, run by InSightec. The registered enrollment target is 14 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (98% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03998657, a NA study of Prostate Cancer, is active but no longer recruiting, sponsored by InSightec.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
- 5
- Study locations
Study Summary
This extended clinical investigation is a multicenter, prospective, single arm study intended to provide continued access of the Exablate Model 2100 device (Exablate Prostate) to patients for treatment of prostate lesions and collect additional safety and effectiveness data during the 510(k) preparation and review period.
Primary Outcome
Safety will be evaluated by incidence and severity of device/procedure-related complications following treatment. Adverse events will be recorded and categorized according to severity and relationship to the biopsy procedure, the Exablate procedure, or to the Exablate device. They will be classified based on body system, severity, and frequency.
Conditions Studied
Interventions
- DEVICE Exablate Prostate Treatment
Study Locations (5)
California
- Stanford University School of Medicine - Stanford
Florida
- Sperling Prostate Center - Delray Beach
Massachusetts
- Brigham & Women's Hospital - Boston
Minnesota
- Mayo Clinic - Rochester
New York
- Memorial Sloan-Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2019-12-19 |
| Est. Completion | 2026-12-30 |
| Phase | NA |
What the registry record for NCT03998657 still lists
NCT03998657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Exablate Prostate Treatment is the first listed.
NCT03998657 lists 5 locations in 5 states (California, Florida, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT03998657 about?
NCT03998657 is a clinical study titled "Continued Access of Focal MR-Guided Focused Ultrasound for Localized Intermediate Risk Prostate Lesions". This extended clinical investigation is a multicenter, prospective, single arm study intended to provide continued access of the Exablate Model 2100 device (Exablate Prostate) to patients for treatment of prostate lesions and collect additional safety and effectiveness data during the 510(k) prepara...
What is the current status of trial NCT03998657?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 14 participants. The study started on 2019-12-19. Estimated completion is 2026-12-30.
What conditions does trial NCT03998657 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT03998657?
The interventions under investigation include: Exablate Prostate Treatment (DEVICE).
Who is sponsoring clinical trial NCT03998657?
This trial is sponsored by InSightec, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03998657 being conducted?
This trial has 5 study locations across California, Florida, Massachusetts, Minnesota, New York. 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 NCT03998657's enrollment target sits among peer trials
14 693rd of 735 higher than 39 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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