Post-Market Clinical Investigation Plan - Collagen Dura Membranes (DM & DMO)

Study Results

Results pending

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.

Recruitment Status

RECRUITING

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-03

Study Completion Date

2025-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Monitoring the Use of Collagen Dura Membrane in the Post-market phase

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Post-Market Clinical Investigation Plan- Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus)

NCT06802133

Repair of Dura Mater

RECRUITING

Clinical Investigation Plan - Post-market Clinical Follow-up Study Collagen Dura Membrane - Suturable

NCT07217132

Repair of Dura Mater

NOT_YET_RECRUITING

Post-market Assessment of Biodesign Dural Repair Grafts

NCT04057157

Cerebrospinal Fluid Leak

COMPLETED

Molecular Characterization of Spinal Tissue

NCT03492372

Spinal Diseases

ENROLLING_BY_INVITATION

Detection of Bacteria in Herniated Nucleus Material in Lumbar Disc Herniations by Culture and PCR

NCT02385968

Lumbar Disc Herniations

TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A multi-center clinical series of 110 patients treated with Collagen Dura Substitute Membrane (DuraMatrix \& DuraMatrix Onlay) for a dural defect in the dura mater will be evaluated prospectively. Patients will have follow-up time points through at least 6-9 months which align with the lifetime of the device. The primary endpoint of the study will be the presence of adverse events leakage that require surgical intervention, will be evaluated at each follow-up time point. The secondary endpoint of the study will be adverse events i.e. infection, Cerebrospinal fluid leak (CSF) and Pseudomeningocele. No patient records or personal identifying information will be disclosed to Collagen Matrix.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Repair of Dura Mater

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with a dural defect requiring repair with a dural substitute.

Exclusion Criteria

* There are no subject restrictions for the study other than patients with known allergy to bovine collagen products as specified in the contraindications of the Instructions for Use.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No