Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04816591
Other study ID # CNV_2020_01
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 27, 2021
Est. completion date May 31, 2025

Study information

Verified date May 2024
Source Cerenovus, Part of DePuy Synthes Products, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 376
Est. completion date May 31, 2025
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Intervention

Device:
Experimental: Interventional Cohort: Treatment Arm
Standard of Care Surgery + Embolization
Other:
Active Comparator: Interventional Cohort: Control Arm
Standard of Care Surgery Only (Control)
Device:
Experimental: Observational Cohort: Treatment Arm
Standard of Care Medical Management + Embolization
Other:
Active Comparator: Observational Cohort: Control Arm
Standard of Care Medical Management Only (Control)

Locations

Country Name City State
United States West Virginia Hospital Morgantown West Virginia
United States Mount Sinai Hospital New York New York

Sponsors (1)

Lead Sponsor Collaborator
Cerenovus, Part of DePuy Synthes Products, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Health Economics Hospital days 365 days post procedure
Primary Effectiveness Hematoma recurrence/progression or requiring re-intervention 180 days post procedure
Secondary Effectiveness Reduction of hematoma volume 180 days post procedure
Secondary Safety: Change in mRS Change in mRS 180 days post procedure
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06347796 - Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study N/A
Recruiting NCT04065113 - Middle Meningeal Artery Embolization for Chronic Subdural Hematoma N/A
Recruiting NCT02938468 - Mgt of Chronic Subdural Hematoma Using Dexamethasone Phase 2/Phase 3
Completed NCT03307395 - Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma N/A
Terminated NCT04502745 - A Study to Evaluate Endoscope-assisted, Minimally-invasive Cortical Access System for Chronic Subdural Evacuation N/A
Terminated NCT03353259 - Tocilizumab (RoActemra) and Tranexamic Acid (Cyklokapron) Used as Adjuncts to Chronic Subdural Hematoma Surgery Phase 2/Phase 3
Recruiting NCT02568124 - Tranexamic Acid in Chronic Subdural Hematomas Phase 2/Phase 3
Completed NCT02282228 - Detecting Chronic Subdural Hematoma With Microwave Technology N/A
Recruiting NCT05143216 - High Concentration Oxygen Therapy for Pneumocephalus in Chronic Subdural Haematoma: A Prospective Observational Study
Recruiting NCT06401772 - The Effectiveness and Safety of Body Posture in Preventing Postoperative Recurrence for Chronic Subdural Hematoma N/A
Completed NCT06134206 - Burr Hole Ultrasound Study N/A
Recruiting NCT03666949 - General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematoma N/A
Recruiting NCT03280212 - Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma Phase 3
Completed NCT03447327 - Outcome of Single Burr Hole Under Local Anaesthesia in the Management of Chronic Subdural Hematoma N/A
Recruiting NCT05374681 - Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization N/A
Recruiting NCT05267184 - Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma N/A
Not yet recruiting NCT05900557 - Neurologic Deficits and Recovery in Chronic Subdural Hematoma N/A
Completed NCT02757235 - The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma N/A
Terminated NCT02111785 - Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma Phase 2/Phase 3
Recruiting NCT05599217 - Association Between Dietary Factors and Chronic Subdural Hematoma (DISH)