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

NCT ID: NCT06802133

Last Updated: 2025-10-15

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

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Recruitment Status

RECRUITING

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-13

Study Completion Date

2026-07-30

Brief Summary

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Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.

Detailed Description

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A prospective, post-market, open label clinical study at a maximum of 8 sites, with an enrollment of 118 subjects. The primary endpoint of the study will be the rate of revision surgery. The presence of adverse events will be evaluated at each follow-up time point i.e. CSF leak, infection and Pseudomeningocele. Patients will have a follow-up evaluation at least at 8 weeks post initial surgery date (which align with the approximate resorption time of the device) where possible and as deemed necessary by a clinician.

No original patient records or personal identifying information will be disclosed to Collagen Matrix.

Conditions

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Repair of Dura Mater

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Post Market Study

Prospective case series without a concurrent comparator group.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The general population will be included in the study where a dura substitute is required for the repair of dura mater.

Exclusion Criteria

* Patients that have conditions which are contraindicated per the instructions for use (IFU) would be excluded.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Collagen Matrix

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Augusta University

Augusta, Georgia, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Meenakshi Paliwal

Role: CONTACT

2014051477 ext. 324

Peggy Hansen

Role: CONTACT

201-405-1477 ext. 304

Facility Contacts

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Candelario Laserna, MD

Role: primary

Natasha Flores

Role: backup

Sophie A Munn

Role: primary

Erica Fox

Role: backup

Other Identifiers

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CIP.057_DMOP

Identifier Type: -

Identifier Source: org_study_id

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