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Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study

NCT06347796 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2026-05-22

No results posted yet for this study

Summary

The goal of this clinical trial is to test in moderately symptomatic chronic subdural hematoma (CSDH) patients if middle meningeal artery embolization (MMAE) can be used as an alternative to conventional open surgery. The main questions it aims to answer are:

* Compared to open conventional surgery, does MMAE reduce the need for rescue surgery or deaths?
* What is the safety of MMAE and conventional open surgery in these patients?

Participants will be asked to:

* Share their medical history and undergo physical examinations
* Have blood drawn
* Have CT scans of the head
* Answer questionnaires
* Undergo MMAE or conventional open surgery
* Provide information about possible adverse events Researchers will compare participants in the MMAE group with those in the conventional open surgery group to see if there is a reduced need for rescue surgery or deaths and evaluate safety.

Conditions

  • Chronic Subdural Hematoma

Interventions

PROCEDURE

Conventional Surgery

Conventional surgery is surgical drainage through burr holes or craniotomy.

DEVICE

Middle Meningeal Artery Embolization (MMAE)

Particle embolization of the middle meningeal artery with micron variants of the Embosphere Microspheres or CONTOUR Embolization Particles device.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2029-02-28
Completion
2029-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT06347796 on ClinicalTrials.gov