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Chronic Subdural HematomaCHESSNCT06347796

Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study

A study testing Conventional Surgery and Middle Meningeal Artery Embolization (MMAE) in people with Chronic Subdural Hematoma, run by The University of Texas Medical Branch, Galveston at 31 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 90 years
Conditions the study is for
Chronic Subdural Hematoma
What is being tested?
Conventional Surgery and Middle Meningeal Artery Embolization (MMAE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
520 participants
Where
31 sitesUnited States
Study dates
1 Nov 2024to Feb 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 40-90 years inclusively.
  • Per CT of the head, (one of the following): Unilateral convexity CSDH measuring at least 10 mm in thickness OR Bilateral CSDH if only one side is considered for treatment (at least 10 mm in thickness) and the contralateral side is asymptomatic and < 10 mm in thickness.
  • CSDH at least 2/3 isodense or hypodense, verified on axial CT slice used to measure the thickness of the qualifying CSDH.
  • Qualifying baseline head CT performed within the 7 days prior to randomization.
  • Able to undergo assigned treatment within 72 hours after randomization.
  • Patient or legally authorized representative agrees to be randomized, and provides written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.

Who cannot join

  • Secondary cause apart from trauma for the qualifying SDH, such as an underlying vascular abnormality or tumor.
  • Tentorial or interhemispheric SDH.
  • Secondary to CSDH, MRC of 0, 1, 2, or 3 in any muscle group contralateral to the side of the CSDH 4.
  • Pre CSDH mRS of 5 or higher.
  • Secondary to CSDH, patient is unable to complete TUG (i.e.,TUG > 120 seconds, unable to walk, or tries TUG but quits in ≤ 120 seconds). Note: This criterion does not apply if the patient does not complete TUG for reason other than CSDH.
  • Secondary to CSDH, ASR of 0, 1, or 2.
Show all 25Show fewer
  • Emergent surgical evacuation such as open craniotomy, burr hole drainage, or Subdural Evacuating Port System (SEPS) is required for the patient.
  • Unable to withhold all antiplatelet agents or OACs for the first 7 days after randomization.
  • Indication that withdrawal of care will be implemented for the qualifying SDH.
  • Prior surgical treatment for CSDH if the surgery is less than 30 days prior to randomization.
  • On tranexamic acid.
  • Platelet count of <100,000 per microliter refractory to transfusion.
  • Coagulopathy that cannot be corrected to an INR of ≤1.5.
  • Known contraindications to angiography.
  • Known intolerance to occlusion procedures.
  • Known vascular anatomy (small artery size) or blood flow (high vascular resistance peripheral to the feeding arteries) that precludes catheter placement or embolic agent (Embosphere Microspheres or CONTOUR particles) injection.
  • Known presence of collateral vessel pathways potentially endangering normal territories or cranial nerves during embolization.
  • Known large diameter arteriovenous shunt, i.e., where the blood does not pass through an arterial/capillary/venous transition but directly from an artery to a vein or presence of patent extra-to-intracranial anastomoses (where study embolization devices could pass directly into the internal carotid artery, vertebral artery, or intracranial vasculature) that cannot be addressed with coil embolization.
  • Patient has a known active systemic infection or sepsis.
  • Patient is pregnant, planning to become pregnant, or lactating.
  • Life expectancy of less than 6 months due to comorbid terminal conditions.
  • Concurrent participation in another research protocol for investigation of an experimental therapy.
  • Known or suspected to not be able to comply with the study protocol.
  • For unilateral CSDH, no measurable deficit secondary to the CSDH on the Timed Up and Go [TUG], Aphasia Severity Rating [ASR], or MRC. At baseline, a measurable deficit on the TUG is defined as: time ≥10 seconds. At baseline, a measurable deficit on the ASR is defined as: a score ≤4. At baseline, a measurable deficit on the MRC is defined as: a score < 5 in any muscle group contralateral to the site of the CSDH.
  • For bilateral CSDH, no measurable deficit secondary to the treatment-eligible CSDH on the ASR or MRC. At baseline, a measurable deficit on the ASR is defined as: a score ≤4. At baseline, a measurable deficit on the MRC is defined as: a score < 5 in any muscle group contralateral to the treatment-eligibile CSDH side.

Trial locations and contacts

31 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jessica Spahn contact

409-266-8859

jlspahn@utmb.edu

Roberto Garcia contact

409-772-3182

robgarci@utmb.edu

31 sites in 1 country

United States31 sites, 29 recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Jonathan Grossberg

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Christopher Stapleton, MD

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Nirav Patel, MD

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Philip Taussky, MD

    Recruiting

  • Cooper University Hospital

    Camden, New Jersey, 08103

    Sean Behnke

    Daniel Tonetti, MD

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22903

    Andrew Carlson, MD

    Recruiting

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220

    Andrew Ringer, MD

    Recruiting

  • University of Missouri Healthcare

    Columbia, Missouri, 65212

    Brooke Hoffman

    Steven Carr

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Babu Welch, MD

    Recruiting

  • JFK Neuroscience Institute, JFK University Medical Center

    Edison, New Jersey, 08820

    Brian Jankowitz, MD

    Recruiting

  • University of Texas Medical Branch

    Galveston, Texas, 77555

    Jessica L Spahn, 409-266-8859, jlspahn@utmb.edu

    Lauren Dawson, 409-354-9792, lndawson@utmb.edu

    Recruiting

  • University of Texas Health Science Center-Houston

    Houston, Texas, 77030

    Sunil Sheth, MD

    Recruiting

  • Baptist Medical Center Jacksonville

    Jacksonville, Florida, 32207

    Ricardo Hanel, MD

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 61660

    Koji Ebersole, MD

    Recruiting

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

    Robert Starke, MD

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Withdrawn

  • Ichan School of Medicine at Mount Sinai

    New York, New York, 10029

    Christopher Kellner, MD

    Recruiting

  • Rutgers, The State University of New Jersey

    Newark, New Jersey, 07101

    Amit Singla, MD

    Recruiting

  • University of Pennyslvania

    Philadelphia, Pennsylvania, 19104

    Jan Burkhardt, MD

    Recruiting

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

    Bernard Bendok, MD

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84132

    Ramesh Grandhi, MD

    Recruiting

  • University of Texas Health Science Center-San Antonio

    San Antonio, Texas, 78229

    Justin Mascitelli, MD

    Recruiting

  • University of Washington

    Seattle, Washington, 98104

    Michael Levitt, MD

    Recruiting

  • Washington University, St. Louis

    St Louis, Missouri, 63110

    Joshua Osbun, MD

    Recruiting

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

    Active, not recruiting

  • University of South Florida

    Tampa, Florida, 33617

    Maxim Mokin, MD

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    David Altschul, MD

    Recruiting

  • Mercy Health St. Vincent Medical Center

    Toledo, Ohio, 43608

    Osama Zaidat, MD

    Not yet recruiting

  • Philadelphia Neurological Institute

    Upland, Pennsylvania, 19013

    Mandy Binning, MD

    Recruiting

  • Westchester Medical Center

    Valhalla, New York, 10595

    Chirag Gandhi, MD

    Recruiting

  • Wake Forest University

    Winston-Salem, North Carolina, 27157

    Stacey Wolfe, MD

    Recruiting

Other trials in United States

About this 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, does MMAE reduce the need for rescue surgery or deaths?
  • What is the safety of MMAE and conventional open surgery in these patients?
Read more

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.
Being tested
Conventional Surgery, Middle Meningeal Artery Embolization (MMAE)
Keywords
chronic subdural hematoma (CSDH), middle meningeal artery embolization (MMAE)
Medical subject headings
Hematoma, Subdural, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional SurgeryProcedure or surgery

    Conventional surgery is surgical drainage through burr holes or craniotomy.

  • Middle Meningeal Artery Embolization (MMAE)Device

    Particle embolization of the middle meningeal artery with micron variants of the Embosphere Microspheres or CONTOUR Embolization Particles device.

Study groups in NCT06347796
Study groupRoleWhat they receive
Middle Menningeal Artery Embolization (MMAE)ExperimentalNot described
Receives: Device: Middle Meningeal Artery Embolization (MMAE)
Conventional Surgery (Craniotomy or Burr Holes)Active comparatorNot described
Receives: Procedure: Conventional Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Need for Rescue Surgery or Death

    Participants who need rescue surgery or die.

    Measured: Within 180-210 days of randomization

Secondary outcomes (1)

  1. Safety of MMAE and Conventional Open Surgery

    The proportion of subjects with symptomatic ischemic stroke, serious/life threatening adverse events, worsening of neurological status (a decline of 1 point on the Markwalder scale) or development of new disabling neurological symptoms, seizures, and/or cranial neuropathy.

    Measured: Within 180 days of randomization.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2024
  2. Study start1 Nov 2024
  3. Primary completionFeb 2029 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
520 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06347796
Sponsor's protocol ID
23-0160
Other IDs
UG3NS128397, UH3NS128397
Acronym
CHESS
Status last verified
May 2026
First submitted
22 Mar 2024
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Surgery and Middle Meningeal Artery Embolization (MMAE) in people with Chronic Subdural Hematoma, run by The University of Texas Medical Branch, Galveston at 31 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jessica Spahn (409-266-8859, jlspahn@utmb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Need for Rescue Surgery or Death (time frame: Within 180-210 days of randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06347796.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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