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Endovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild Symptoms

NCT06274580 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-02-23

No results posted yet for this study

Summary

Embotrial-1 is an Italian multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment (PROBE) to assess the superiority of MMA embolization compared to conservative treatment. The intervention group is MMA embolization and comparator control group is the conservative management with best medical treatment. Patients are randomized 1:1.

Conditions

  • Subdural Hematoma, Chronic

Interventions

DEVICE

embolization of the middle meningeal artery

Embolization of the MMA is occluded with PVA particles or liquid embolizing materials

Sponsors & Collaborators

  • Ospedale Policlinico San Martino

    lead OTHER

Principal Investigators

  • Lucio Castellan, MD · Ospedale Policlinico San Martino

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-03-01
Completion
2026-03-01
FDA Device
Yes

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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 NCT06274580 on ClinicalTrials.gov