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Template-Guided Burr-Hole Drainage With Middle Meningeal Artery Coagulation for Chronic Subdural Hematoma

NCT07720687 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2026-07-23

No results posted yet for this study

Summary

Chronic subdural hematoma is a collection of blood and fluid on the surface of the brain that is common in older adults. Burr-hole drainage is a standard surgical treatment, but the hematoma may come back in some patients and require another procedure.This study will test whether using a patient-specific 3D-printed template to guide burr-hole placement, combined with coagulation of the middle meningeal artery during surgery, can reduce the risk of hematoma recurrence compared with standard burr-hole drainage.Participants with symptomatic chronic subdural hematoma who need surgery will be randomly assigned to one of two groups. One group will receive standard burr-hole drainage. The other group will receive 3D-printed template-guided burr-hole drainage with attempted intraoperative frontal branch of the middle meningeal artery coagulation when it can be safely performed.The main outcome is whether the hematoma comes back and requires another invasive treatment within 3 months after surgery. The study will also assess brain imaging results, neurological recovery, complications, hospital stay, and the feasibility and safety of the 3D-printed template and artery coagulation procedure.

Conditions

  • Chronic Subdural Hematoma

Interventions

PROCEDURE

Standard Burr-Hole Drainage Group

Standard burr-hole drainage performed according to routine clinical practice for chronic subdural hematoma.

PROCEDURE

3D-Printed Template-Guided Burr-Hole Drainage With Attempted MMA Coagulation Group

Burr-hole drainage performed using a patient-specific 3D-printed template for surgical guidance, combined with attempted intraoperative coagulation of the middle meningeal artery.

Sponsors & Collaborators

  • Xijing Hospital

    collaborator OTHER

  • The Second Hospital of Anhui Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2028-12-31
Completion
2029-06-30

Countries

  • China

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 NCT07720687 on ClinicalTrials.gov