Post-Market Clinical Investigation Plan- Collagen Dural R... | NCT06802133

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

NCT06802133

Sponsor

Collagen Matrix

Status

Recruiting

Last Update Posted

Oct 15, 2025Actual

Enrollment

118Estimated

Phase

Not provided

Conditions

Repair of Dura Mater

Interventions

Post Market Study

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 13, 2025Actual

Primary Completion Date

May 30, 2026Estimated

Completion Date

Jul 30, 2026Estimated

First Submitted Date

Jan 27, 2025

First Submission Date that Met QC Criteria

Jan 27, 2025

First Posted Date

Jan 31, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2025

Last Update Posted Date

Oct 15, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

118Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Post Market Study	Other	Prospective case series without a concurrent comparator group.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of Revision Surgery	Adequate healing of dural defects without need for a revision surgery or second intervention	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Rate of Adverse events	Rate of product-related adverse events or complications	8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Meenakshi Paliwal	Contact	2014051477	324	mpaliwal@regenity.com
Peggy Hansen	Contact	201-405-1477	304	phansen@regenity.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Augusta University	Recruiting	Augusta	Georgia	30912	United States