Prospective Multi-center Single Arm Study for Subjects With Chronic Subdural Hematoma Treated With i-ED COILs, Either Alone or in Combination With Burr-holes or Mini-craniotomy
NCT ID: NCT07214623
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
200 participants
OBSERVATIONAL
2025-11-30
2027-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Chronic Subdural Hematoma Embolization With Detachable Coils
NCT07291427
Endovascular Embolization for Chronic Subdural Hematomas Following Surgical Evacuation
NCT04272996
Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma
NCT03307395
The CHALLENGER Registry
NCT07197840
Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study
NCT06347796
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Neuro endovascular embolic coil
i-ED COIL, Kaneka Corporation
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Chronic subdural symptomatic, requiring intervention
Exclusion Criteria
* Intercranial mass other than subdural hematoma
* Females pregnant or breast feeding
* Compromised survival or inability to complete trial
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kaneka Medical America LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fawaz Al-Mufti, MD
Role: PRINCIPAL_INVESTIGATOR
Westchester Medical Center
Jan-Karl Burkhardt, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Westchester Medical Center
Valhalla, New York, United States
University of Pennslyvania
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLIN-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.