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RECRUITING NA

Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study

NCT06347796 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06347796

The ClinicalTrials.gov registry entry for NCT06347796 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 520 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Medical Branch, Galveston, which has 132 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06347796 reports 20 study locations spanning 10 distinct geographic areas — top geographies include New York, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06347796?

The interventions under investigation include: Conventional Surgery (PROCEDURE), Middle Meningeal Artery Embolization (MMAE) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06347796?

This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 132 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial