Post-market Clinical Investigation Plan: Collagen Dura Regeneration Membrane - Repair (DMR)

Monitoring the Use of Collagen Dura Membrane - Repair (DMR) in the Post-market Phase

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07371091

Enrollment

110

Registered

2026-01-27

Start date

2026-07-01

Completion date

2027-12-01

Last updated

2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Repair of Dura Mater

Brief summary

Monitoring the Use of Collagen Dura Regeneration Membrane - Repair (DMR) in the Post-market Phase.

Detailed description

A multi-center (up to 4 sites) clinical case series of 110 patients treated with Collagen Dura Regeneration Membrane - Repair (DMR) for a dural defect in the dura mater will be evaluated prospectively. The primary endpoint is the rate of adverse events related to the Subject Device requiring surgical intervention. Patients will have a follow-up evaluation post-operatively in line with standard or care of the study site, and 8 months after the initial surgery. No original patient records or personal identifying information will be disclosed to CMI.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with a dural defect requiring repair with a dural substitute as per routine clinical practice * Patient is 18 years or older * Patient of child-bearing potential is not pregnant or nursing * Participant is willing and able to provide consent

Exclusion criteria

* Patients with a known history of hypersensitivity to bovine derived materials * Patients that are non-English speaking * Patients requiring legal representation

Design outcomes

Primary

Measure	Time frame	Description
Rate of Revision Surgery	at least one timepoint at 8 months or more post-surgery	Rate of adverse events related to the Subject Device requiring surgical intervention.

Secondary

Measure	Time frame	Description
Rate of Adverse Events	at least one timepoint at 8 months or more post-surgery	Intra-operative and post-operative adverse events (i.e., infection, CSF Leak, and Pseudomeningocele)
Product Performance	at least one timepoint at 8 months or more post-surgery	Score of adequacy of product performance - 1 (poor) to 4 (excellent)
Product Handling at Implantation	Initial surgery	Score for product handling at implantation - 1 (poor) to 4 (excellent)
Product Adaptability at Implantation	Initial surgery	Score for product adaptability at implantation - 1 (poor) to 4 (excellent)

Countries

United States

Contacts

CONTACTMeenakshi Paliwal

mpaliwal@regenity.com347-439-1634

CONTACTSarah Grace Dennis-Little, PhD

sgdennislittle@regenity.com706-247-0251

Outcome results