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Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption

NCT03551249 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety of the ExAblate Model 4000 Type 2 used as a tool to disrupt the BBB (blood brain barrier) in patients with high grade glioma undergoing standard of care therapy.

Conditions

Interventions

DEVICE

Focused ultrasound (FUS)

FUS involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct body targets.

Sponsors & Collaborators

  • InSightec

    lead INDUSTRY

Principal Investigators

  • Graeme Woodworth, MD · University of Maryland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-26
Primary Completion
2023-12-31
Completion
2023-12-31
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 NCT03551249 on ClinicalTrials.gov