NCT07371091

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Feb 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Feb 2026Dec 2027

First Submitted

Initial submission to the registry

January 19, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

January 19, 2026

Last Update Submit

January 19, 2026

Conditions

Repair of Dura Mater

Outcome Measures

Primary Outcomes (1)

  • Rate of Revision Surgery

    Rate of adverse events related to the Subject Device requiring surgical intervention.

    at least one timepoint at 8 months or more post-surgery

Secondary Outcomes (4)

  • Rate of Adverse Events

    at least one timepoint at 8 months or more post-surgery

  • Product Performance

    at least one timepoint at 8 months or more post-surgery

  • Product Handling at Implantation

    Initial surgery

  • Product Adaptability at Implantation

    Initial surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with a dural defect requiring repair with a dural substitute.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Meenakshi Paliwal

CONTACT

347-439-1634mpaliwal@regenity.com

Sarah Grace Dennis-Little, PhD

CONTACT

706-247-0251sgdennislittle@regenity.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2026

First Posted

January 27, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 27, 2026

Record last verified: 2026-01