NCT07217132

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
16mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

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 Progress25%
Dec 2025Sep 2027

First Submitted

Initial submission to the registry

October 13, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 15, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

October 15, 2025

Status Verified

October 1, 2025

Enrollment Period

1.8 years

First QC Date

October 13, 2025

Last Update Submit

October 13, 2025

Conditions

Repair of Dura Mater

Outcome Measures

Primary Outcomes (1)

  • Rate of Adverse Events Requiring Surgical Intervention

    Rate of adverse events related to subject device and requiring surgical intervention.

    9 months

Secondary Outcomes (4)

  • Rate of Adverse Events

    9 months

  • Score of adequacy of product performance

    9 months

  • Score for Product Handling at Implantation

    9 months

  • Score for Product Adaptability at Implantation

    9 months

Interventions

Post-market StudyOTHER

Prospective case series without a concurrent comparator group.

Eligibility Criteria

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

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baptist Health South Florida

Miami, Florida, 33176, United States

Location

Central Study Contacts

Meenakshi Paliwal

CONTACT

2014051477mpaliwal@regenity.com

Peggy Hansen

CONTACT

2014051477phansen@regenity.com

Study Design

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

Study Record Dates

First Submitted

October 13, 2025

First Posted

October 15, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

October 15, 2025

Record last verified: 2025-10

Locations

US(1)