- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04816591
Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA (MEMBRANE)
March 26, 2024 updated by: Cerenovus, Part of DePuy Synthes Products, Inc.
This is a prospective, multi-center, open-label, randomized controlled study in which subjects can receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of chronic subdural hematomas (cSDH).
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
This is a prospective, multi-center, open-label, randomized controlled study in which up to 376 subjects will be randomized to receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of cSDH.
Study Type
Interventional
Enrollment (Actual)
376
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lillian Ma
- Phone Number: 9494668021
- Email: lma46@its.jnj.com
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Mount Sinai Hospital
-
-
West Virginia
-
Morgantown, West Virginia, United States, 26506
- West Virginia Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Pre-randomization mRS </= 3
- Confirmed diagnosis of chronic subdural hematoma
- Completed informed consent
Exclusion Criteria:
- Acute subdural hematoma
- Prior treatment of target subdural hematoma
- Markwalder assessment >/= 3
- Glasgow Coma Scale < 9
- Presumed microbial superinfection
- CT or MRI evidence of intracranial tumor or mass lesion
- Life expectancy < 1 year
- Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during the study
- Current involvement in another clinical trial that may confound study endpoints
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: Interventional Cohort: Treatment Arm
Standard of Care Surgery + Embolization
|
Standard of Care Surgery + Embolization
|
Active Comparator: Active Comparator: Interventional Cohort: Control Arm
Standard of Care Surgery Only
|
Standard of Care Surgery Only (Control)
|
Experimental: Experimental: Observational Cohort: Treatment Arm
Standard of Care Medical Management + Embolization
|
Standard of Care Medical Management + Embolization
|
Active Comparator: Active Comparator: Observational Cohort: Control Arm
Medical Management Only
|
Standard of Care Medical Management Only (Control)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness
Time Frame: 180 days post procedure
|
Hematoma recurrence/progression or requiring re-intervention
|
180 days post procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness
Time Frame: 180 days post procedure
|
Reduction of hematoma volume
|
180 days post procedure
|
Safety: Change in mRS
Time Frame: 180 days post procedure
|
Change in mRS
|
180 days post procedure
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health Economics
Time Frame: 365 days post procedure
|
Hospital days
|
365 days post procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christopher Kellner, MD, Mount Sinai Hospital
- Principal Investigator: Ansaar Rai, MD, West Virginia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 27, 2021
Primary Completion (Estimated)
May 31, 2024
Study Completion (Estimated)
May 31, 2025
Study Registration Dates
First Submitted
March 23, 2021
First Submitted That Met QC Criteria
March 23, 2021
First Posted (Actual)
March 25, 2021
Study Record Updates
Last Update Posted (Actual)
March 27, 2024
Last Update Submitted That Met QC Criteria
March 26, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Disease Attributes
- Hemorrhage
- Craniocerebral Trauma
- Trauma, Nervous System
- Intracranial Hemorrhages
- Intracranial Hemorrhage, Traumatic
- Chronic Disease
- Hematoma
- Hematoma, Subdural
- Hematoma, Subdural, Chronic
Other Study ID Numbers
- CNV_2020_01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health.
Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Subdural Hematoma
-
University Hospital, MontpellierHospices Civils de Lyon; Centre Hospitalier Universitaire de Nice; University... and other collaboratorsTerminatedChronic Intracranial Subdural HematomaFrance
-
Ataturk Training and Research HospitalCompletedSubdural Hematoma, ChronicTurkey
-
Ospedale Policlinico San MartinoNot yet recruitingEndovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild SymptomsSubdural Hematoma, Chronic
-
Balt USAAXIOM Real Time Metrics; Embo-Flüssigkeiten A.G.; Balt ExtrusionActive, not recruitingSubdural Hematoma, ChronicUnited States, France, Germany, Spain
-
Rennes University HospitalCompleted
-
Academisch Medisch Centrum - Universiteit van Amsterdam...RecruitingChronic Subdural HematomasNetherlands
-
Chinese University of Hong KongWithdrawnChronic Subdural Hematoma | Subdural HematomaChina
-
The University of Texas Medical Branch, GalvestonNational Institute of Neurological Disorders and Stroke (NINDS)Not yet recruitingChronic Subdural HematomaUnited States
-
Cairo UniversityCompletedMonitored Anaesthesia Care | Loco-regional Chronic Subdural Hematoma EvacuationEgypt
-
Kwong Wah HospitalUnknownChronic Subdural Hematoma | Subdural DrainChina
Clinical Trials on Experimental: Interventional Cohort: Treatment Arm
-
Fundación Renal Iñigo Alvarez De ToledoEffice Servicios Para la Investigacion S.L.TerminatedChronic Kidney Disease, UnspecifiedSpain
-
Umm Al-Qura UniversityCompletedCerebral PalsySaudi Arabia
-
Guy's and St Thomas' NHS Foundation TrustB&D ElectromedicalCompletedExcessive Dynamic Airway Collapse | TracheobronchomalaciaUnited Kingdom
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingHPV | Related Malignancy | Related CarcinomaUnited States
-
Manchester Academic Health Science CentreErasmus Medical Center; Tommy's; Academy of Medical Sciences, UKActive, not recruitingPregnancy Complications | Placenta Diseases | Fetal Growth Retardation | Preeclampsia | IVFUnited Kingdom
-
Institut Claudius RegaudInstitute of Cancer Research, United Kingdom; Hellenic Cooperative Oncology... and other collaboratorsRecruitingAdenocarcinoma | Cervical Carcinoma | Adenosquamous CarcinomaFrance, Italy, Spain
-
Ages et Vies AssociationCaisse Nationale de Solidarité pour l'Autonomie; National Insurance Fund Vieilleisse and other collaboratorsCompleted
-
Vanderbilt University Medical CenterNational Institutes of Health (NIH); National Institute of General Medical...Active, not recruitingDelirium | Critical Illness | Cognitive Impairment | Trauma | Traumatic Brain Injury | ICU | Polytrauma | Alzheimer; Early OnsetUnited States
-
Northwestern UniversityCompleted
-
MPM MedicalTexas Health ResourcesRecruiting