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ExAblate Blood Brain Barrier Disruption (BBBD) for Planned Surgery in Suspected Infiltrating Glioma

NCT03322813 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-08-03

No results posted yet for this study

Summary

This study is designed to assess the safety and feasibility of using the ExAblate, Type 2 to temporarily disrupt the blood brain barrier in non-enhancing suspected infiltrating glioma. The ExAblate Model 4000 Type-2 is intended for use as a tool to disrupt the BBB.

Conditions

Interventions

DEVICE

ExAblate 4000 - Type 2

Using ExAblate Model 4000 Type-2 to temporarily disrupt the blood brain barrier in non-enhancing suspected infiltrating glioma undergoing resection

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
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2024-09-30
Completion
2024-12-31
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 NCT03322813 on ClinicalTrials.gov