NCT06802133

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Jan 2025

Geographic Reach
1 country

2 active sites

Status
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 Progress85%
Jan 2025Jul 2026

Study Start

First participant enrolled

January 13, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

October 15, 2025

Status Verified

October 1, 2025

Enrollment Period

1.4 years

First QC Date

January 27, 2025

Last Update Submit

October 14, 2025

Conditions

Repair of Dura Mater

Outcome Measures

Primary Outcomes (1)

  • Rate of Revision Surgery

    Adequate healing of dural defects without need for a revision surgery or second intervention

    8 weeks

Secondary Outcomes (1)

  • Rate of Adverse events

    8 weeks

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:

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

You may not qualify if:

  • Patients that have conditions which are contraindicated per the instructions for use (IFU) would be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Central Study Contacts

Meenakshi Paliwal

CONTACT

2014051477mpaliwal@regenity.com

Peggy Hansen

CONTACT

201-405-1477phansen@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 27, 2025

First Posted

January 31, 2025

Study Start

January 13, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

October 15, 2025

Record last verified: 2025-10

Locations

US(2)