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NCT04816591 · ClinicalTrials.gov registry record · NA
Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
A NA study, sponsored by Cerenovus, Part of DePuy Synthes Products.
- Completed
- Registry status
- NA
- Development phase
- 376
- Enrollment target
NCT04816591 is a NA study that has completed, run by Cerenovus, Part of DePuy Synthes Products. The registered enrollment target is 376 participants.
The verdict
NCT04816591, a NA study, has completed, sponsored by Cerenovus, Part of DePuy Synthes Products.
- COMPLETED
- Registry status
- NA
- Development phase
- 376 participants
- Enrollment target
Study Summary
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).
Interventions
- DEVICE Experimental: Interventional Cohort: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
- OTHER Standard of Care Surgery
- DEVICE Experimental: Interventional Cohort: TRUFILL n-BCA Liquid Embolic System
- OTHER Standard of Care Medical Management
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 376 participants |
| Start Date | 2021-05-27 |
| Est. Completion | 2025-03-26 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04816591
The ClinicalTrials.gov registry entry for NCT04816591 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 376 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cerenovus, Part of DePuy Synthes Products, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Experimental: Interventional Cohort: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System is the first listed.
NCT04816591 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04816591 about?
NCT04816591 is a clinical study titled "Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA". 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).
What is the current status of trial NCT04816591?
This trial is currently completed. It is a NA study. The enrollment target is 376 participants. The study started on 2021-05-27. Estimated completion is 2025-03-26.
What interventions are being tested in trial NCT04816591?
The interventions under investigation include: Experimental: Interventional Cohort: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (DEVICE), Standard of Care Surgery (OTHER), Experimental: Interventional Cohort: TRUFILL n-BCA Liquid Embolic System (DEVICE), Standard of Care Medical Management (OTHER).
Who is sponsoring clinical trial NCT04816591?
This trial is sponsored by Cerenovus, Part of DePuy Synthes Products, which has 5 total clinical trials registered on ClinicalTrials.gov.
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