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

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

NOT_YET_RECRUITING

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-09-30

Brief Summary

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Monitoring the use of Collagen Dura Membrane - Suturable (DMS) in the post-market phase

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Detailed Description

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A prospective, post-market clinical study at a maximum of three sites, with an enrollment of 54 subjects. The primary endpoint of the study will be the rate of adverse events related to the Subject Device requiring surgical intervention. The date of each event will be recorded and assessed, including at least one timepoint of 9 months of more post-operatively. Secondary endpoints will include all adverse events (i.e., infection, CSF Leak, and Pseudomeningocele), score of adequacy of product performance, score for product handling at implantation, and score for product adaptability at implantation.

No original patient records or patient 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

* Patients with a dural defect requiring repair with a dural substitute
* Patient is 18 years or older
* Patient of child-bearing potential is not pregnant or nursing

Exclusion Criteria

* Patients with a known history of hypersensitivity to bovine derived materials
* Patients that are non-English speaking
* Subjects requiring Legally Authorized Representative

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No