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Managing Non-acute Subdural Hematoma Using Liquid Materials：a Chinese Randomized Trial of MMA Treatment

NCT04700345 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 722

Last updated 2024-04-30

No results posted yet for this study

Summary

MAGIC-MT study is multi-center, prospective, randomized (1:1) controlled trial designed to show that additional MMA embolization with Onyx in patients with non-acute symptomatic subdural hematoma(SDH) results in reduced hematoma recurrence in surgically treated patients/ reduced hematoma progression in conservatively managed patients.

Conditions

  • Subdural Hematoma, Non-acute

Interventions

DEVICE

Onyx

Embolization of the Middle Meningeal Artery using the liquid embolic material

PROCEDURE

Burr-hole

Burr-hole drainage of subdural hematoma

OTHER

Medical Management

best medical management

Sponsors & Collaborators

  • Shanghai Municipal Health Commission

    collaborator UNKNOWN

  • Shanghai Shen Kang Hospital Development Center

    collaborator OTHER

  • Huashan Hospital

    lead OTHER

Principal Investigators

  • Ying Mao, PhD · department of Neurosurgery, Huashan Hospital,Fudan University

  • Jian Min Liu, MD · Neurovascular Center, Trauma Center, Changhai Hospital, Naval Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-21
Primary Completion
2023-08-17
Completion
2024-06-17
FDA Device
Yes

Countries

  • China

Study Locations

More Related Trials

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 NCT04700345 on ClinicalTrials.gov