NCT06347796

Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2029-02-01
• Completion: 2029-02-01
• First posted: 2024-04-04
• Last updated: 2026-03-12

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated device study