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NCT06347796 · ClinicalTrials.gov registry record · NA

Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study

A NA study of Chronic Subdural Hematoma, sponsored by The University of Texas Medical Branch, Galveston.

Recruiting
Registry status
NA
Development phase
520
Enrollment target
20
Study locations

NCT06347796: Recruiting NA study of Chronic Subdural Hematoma, sponsored by The University of Texas Medical Branch, Galveston.

NCT06347796 is a NA study of Chronic Subdural Hematoma that is actively recruiting participants, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 520 participants, below the 1,312-participant average among 4 other Chronic Subdural Hematoma trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06347796, a NA study of Chronic Subdural Hematoma, is actively recruiting participants, sponsored by The University of Texas Medical Branch, Galveston.

RECRUITING
Registry status
NA
Development phase
520 participants
Enrollment target
20
Study locations

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.

Primary Outcome

Participants who need rescue surgery or die.

Conditions Studied

Chronic Subdural Hematoma

Interventions

  • PROCEDURE Conventional Surgery
  • DEVICE Middle Meningeal Artery Embolization (MMAE)

Study Locations (20)

New York

  • Ichan School of Medicine at Mount Sinai - New York
  • SUNY Upstate Medical University - Syracuse
  • Montefiore Medical Center - The Bronx
  • Westchester Medical Center - Valhalla

Florida

  • Baptist Medical Center Jacksonville - Jacksonville
  • University of Miami Miller School of Medicine - Miami
  • University of South Florida - Tampa

Massachusetts

  • Massachusetts General Hospital - Boston
  • Brigham and Women's Hospital - Boston
  • Beth Israel Deaconess Medical Center - Boston

New Jersey

  • Cooper University Hospital - Camden
  • JFK Neuroscience Institute, JFK University Medical Center - Edison
  • Rutgers, The State University of New Jersey - Newark

Missouri

  • University of Missouri Healthcare - Columbia
  • Washington University, St. Louis - St Louis

Arizona

  • Mayo Clinic Arizona - Phoenix

Georgia

  • Emory University - Atlanta

Kansas

  • University of Kansas Medical Center - Kansas City

Trial Details

FieldValue
Enrollment Target 520 participants
Start Date 2024-11-01
Est. Completion 2029-02
Phase NA
The University of Texas Medical Branch, Galveston

203 total trials

What NCT06347796 shows while recruiting

NCT06347796 is an interventional study that assigns participants to a tested intervention. The registered 520 participants enrollment target is mid-sized for trials with a published cap, below the 1,312-participant average among 4 other Chronic Subdural Hematoma trials with a reported enrollment target (60% lower).

The record links to 1 condition, with Chronic Subdural Hematoma appearing as the primary indexed condition, and to 2 interventions - of which Conventional Surgery is the first listed.

NCT06347796 names 20 study sites across 10 states, led by New York, Florida, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06347796 about?

NCT06347796 is a clinical study titled "Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study". 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...

What is the current status of trial NCT06347796?

This trial is currently recruiting. It is a NA study. The enrollment target is 520 participants. The study started on 2024-11-01. Estimated completion is 2029-02.

What conditions does trial NCT06347796 study?

This clinical trial studies the following conditions: Chronic Subdural Hematoma.

What interventions are being tested in trial NCT06347796?

The interventions under investigation include: Conventional Surgery (PROCEDURE), Middle Meningeal Artery Embolization (MMAE) (DEVICE).

Who is sponsoring clinical trial NCT06347796?

This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06347796 being conducted?

This trial has 20 study locations across Arizona, Florida, Georgia, Kansas, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT06347796

Source: ClinicalTrials.gov NCT06347796, the US trial registry maintained by the National Library of Medicine. NCT06347796 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.