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Continued Access of Focal MR-Guided Focused Ultrasound for Localized Intermediate Risk Prostate Lesions

NCT03998657 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-05-01

No results posted yet for this 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

Interventions

DEVICE

Exablate Prostate Treatment

The Exablate system is a non-invasive thermal ablation device that is being used to ablate tissue. The system combines a focused ultrasound surgery (FUS) delivery system and MRI scanner.

Sponsors & Collaborators

  • InSightec

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-19
Primary Completion
2026-12-30
Completion
2026-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03998657 on ClinicalTrials.gov