NCT04923867

Brief Summary

The primary goal of this study is to retrospectively collect data on the safety and efficacy of Suturable DuraGen™.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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 Start

First participant enrolled

April 28, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

3.3 years

First QC Date

June 7, 2021

Last Update Submit

April 3, 2025

Conditions

Cerebrospinal Fluid Leak

Outcome Measures

Primary Outcomes (1)

  • Patient Outcome

    Occurrence of post-operative cerebrospinal fluid (CSF) leaks post-procedure

    post-up to 90 days

Secondary Outcomes (1)

  • Occurrence of Adverse Event

    Between days 30-90

Study Arms (3)

Supratentorial Procedure Group

Subjects that have undergone a supratentorial procedure with the use of Suturable DuraGen™.

Device: Suturable DuraGen™

Infratentorial Procedure Group

Subjects that have undergone a infratentorial procedure with the use of Suturable DuraGen™.

Device: Suturable DuraGen™

Spinal Procedure Group

Subjects that have undergone a spinal procedure with the use of Suturable DuraGen™.

Device: Suturable DuraGen™

Interventions

Suturable DuraGen™DEVICE

Suturable DuraGen™ Dural Regeneration Matrix, an absorbable implant for repair of dural defects.

Infratentorial Procedure GroupSpinal Procedure GroupSupratentorial Procedure Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Neurosurgery service in Hospital

You may qualify if:

  • Subject is between 18 and 80 years of age
  • Subject has undergone either a supratentorial, an infratentorial, or a spinal procedure with the use of Suturable DuraGen™ prior to trial initiation
  • Availability of post-operative assessment results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Baptist Medical Center

Jacksonville, Florida, 32207, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Cerebrospinal Fluid Leak

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Andrew Tummon

    Integra LifeSciences

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 11, 2021

Study Start

April 28, 2021

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

April 6, 2025

Record last verified: 2025-04

Locations

US(3)