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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.

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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

FieldValue
Enrollment Target 376 participants
Start Date 2021-05-27
Est. Completion 2025-03-26
Phase NA

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.