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

NCT06822920 | Recruiting

• 1 other identifier: CIP.010
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Repair of Dura Mater

Outcome Measures

Primary Outcomes (1)

• Measurement of the occurrence of adverse event requiring surgical intervention

  6-9 months

Secondary Outcomes (1)

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

  6-9 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The subject device is intended for all patient populations. The following population is excluded from the study:- * Pregnant Women * Subjects requiring Legally Authorized Representative * Subjects under 18 years of age

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Collagen Matrix: lead

Study Sites (1)

Medical Collagen of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Central Study Contacts

Meenakshi Paliwal

CONTACT

2014051477; mpaliwal@regenity.com

Peggy Hansen

CONTACT

201-405-1477; phansen@regenity.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 12, 2025
• Study Start: January 3, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

US (1)