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Continued Access of Focal MR-Guided Focused Ultrasound for Localized Intermediate Risk Prostate Lesions
NCT03998657 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03998657
The ClinicalTrials.gov registry entry for NCT03998657 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is InSightec, which has 76 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03998657 reports 5 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03998657?
The interventions under investigation include: Exablate Prostate Treatment (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03998657?
This trial is sponsored by InSightec, which has 76 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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