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Recruiting

NCT Number: NCT06822920

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

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

Recruiting

Interested in participating?

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Key information

Conditions

Repair of Dura Mater

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Collagen of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location status: Recruiting

Location contact

Kaitlin Goetschel

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Measurement of the occurrence of adverse event requiring surgical intervention

    Time frame: 6-9 months

Secondary outcomes

  1. Adverse events i.e., infection, CSF leak and Pseudomeningocele

    Time frame: 6-9 months

Study contacts

Contact information is provided by the study sponsor or research team.

Meenakshi Paliwal

CONTACT

[email protected]

2014051477 ext. 324

Peggy Hansen

CONTACT

[email protected]

201-405-1477 ext. 304

Sponsors and collaborators

Lead sponsor

Collagen Matrix

Industry

Registry information

Official study title

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

Acronym: DM&DMO

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2025
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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