Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
The University of Texas Medical Branch, Galveston
Study ID
NCT06347796
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Subdural Hematoma

Eligibility Criteria

Sex
ALL
Age
40 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Conventional Surgery — PROCEDURE
    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 Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
May 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
520 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Middle Menningeal Artery Embolization (MMAE)
  • Active Comparator: Conventional Surgery (Craniotomy or Burr Holes)

Primary Outcome Measure

Need for Rescue Surgery or Death [ Time Frame: Within 180-210 days of randomization ]

Central Contacts

Locations (31)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona85054
Bernard Bendok, MD (PRINCIPAL_INVESTIGATOR)
Baptist Medical Center JacksonvilleJacksonvilleFlorida32207
Ricardo Hanel, MD (PRINCIPAL_INVESTIGATOR)
University of Miami Miller School of MedicineMiamiFlorida33136
Robert Starke, MD (PRINCIPAL_INVESTIGATOR)
University of South FloridaTampaFlorida33617
Maxim Mokin, MD (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30322
Jonathan Grossberg (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical CenterKansas CityKansas61660
Koji Ebersole, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Philip Taussky, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
Nirav Patel, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Christopher Stapleton, MD (PRINCIPAL_INVESTIGATOR)
University of MinnesotaMinneapolisMinnesota55455-
University of Missouri HealthcareColumbiaMissouri65212
Brooke Hoffman
Steven Carr (PRINCIPAL_INVESTIGATOR)
Washington University, St. LouisSt LouisMissouri63110
Joshua Osbun, MD (PRINCIPAL_INVESTIGATOR)
Cooper University HospitalCamdenNew Jersey08103
Sean Behnke
Daniel Tonetti, MD (PRINCIPAL_INVESTIGATOR)
JFK Neuroscience Institute, JFK University Medical CenterEdisonNew Jersey08820
Brian Jankowitz, MD (PRINCIPAL_INVESTIGATOR)
Rutgers, The State University of New JerseyNewarkNew Jersey07101
Amit Singla, MD (PRINCIPAL_INVESTIGATOR)
Ichan School of Medicine at Mount SinaiNew YorkNew York10029
Christopher Kellner, MD (PRINCIPAL_INVESTIGATOR)
SUNY Upstate Medical UniversitySyracuseNew York13210-
Montefiore Medical CenterThe BronxNew York10467
David Altschul, MD (PRINCIPAL_INVESTIGATOR)
Westchester Medical CenterValhallaNew York10595
Chirag Gandhi, MD (PRINCIPAL_INVESTIGATOR)
Wake Forest UniversityWinston-SalemNorth Carolina27157
Stacey Wolfe, MD (PRINCIPAL_INVESTIGATOR)
Good Samaritan HospitalCincinnatiOhio45220
Andrew Ringer, MD (PRINCIPAL_INVESTIGATOR)
Mercy Health St. Vincent Medical CenterToledoOhio43608
Osama Zaidat, MD (PRINCIPAL_INVESTIGATOR)
University of PennyslvaniaPhiladelphiaPennsylvania19104
Jan Burkhardt, MD (PRINCIPAL_INVESTIGATOR)
Philadelphia Neurological InstituteUplandPennsylvania19013
Mandy Binning, MD (PRINCIPAL_INVESTIGATOR)
UT Southwestern Medical CenterDallasTexas75390
Babu Welch, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Medical BranchGalvestonTexas77555
Jessica L Spahn
[email protected]
409-266-8859
Lauren Dawson
[email protected]
409-354-9792
Peter Kan, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center-HoustonHoustonTexas77030
Sunil Sheth, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center-San AntonioSan AntonioTexas78229
Justin Mascitelli, MD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84132
Ramesh Grandhi, MD (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22903
Andrew Carlson, MD (PRINCIPAL_INVESTIGATOR)
University of WashingtonSeattleWashington98104
Michael Levitt, MD (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic Arizona· Phoenix, AZBaptist Medical Center Jacksonville· Jacksonville, FLUniversity of Miami Miller School of Medicine· Miami, FLUniversity of South Florida· Tampa, FLEmory University· Atlanta, GAUniversity of Kansas Medical Center· Kansas City, KS

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