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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: Completed NA study, sponsored by Cerenovus, Part of DePuy Synthes Products.
NCT04816591 is a NA study that has completed, run by Cerenovus, Part of DePuy Synthes Products. The registered enrollment target is 376 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Percentage of participants and odds ratio (OR) of participants with residual or re-accumulation of the cSDH (\>10 mm) at 6 months as assessed by an independent core laboratory or re-operation or surgical procedure on the cSDH at 6 months post-randomization in the treatment with eMMA vs. standard of care is represented. Residual or re-accumulation of the cSDH \>10 mm was a threshold included in the guidelines for surgical evacuation and was considered to be of prognostic importance given its asso
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 |
What the finished NCT04816591 record still lists
NCT04816591 is an interventional study that assigns participants to a tested intervention. The registered 376 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (73% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04816591's enrollment target sits among peer trials
376 274th of 2000 higher than 1,725 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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