NCT04057157

Brief Summary

The purpose of this clinical study is to gather post-market clinical evidence on the use of the Biodesign® Dural and Duraplasty Grafts when used as a dura substitute of the dura mater.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
3 countries

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

First Submitted

Initial submission to the registry

August 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

September 3, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

October 14, 2022

Status Verified

October 1, 2022

Enrollment Period

2.8 years

First QC Date

August 13, 2019

Last Update Submit

October 13, 2022

Conditions

Cerebrospinal Fluid Leak

Keywords

dura mater repaircerebrospinal fluid leakCSF leakBiodesign® Dural Repair GraftBiodesign® Duraplasty Repair Graft

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients without clinically relevant cerebrospinal fluid (CSF) leakage

    Clinically relevant CSF leakage is when it requires treatment (e.g., lumbar drain or surgical repair) or leads to an infection of the central nervous system (e.g., meningitis).

    2 months

Interventions

Biodesign Dural or Duraplasty Repair GraftsDEVICE

Patients will receive the Biodesign Dural or Duraplasty Repair Grafts according to the Instruction for Use.

Eligibility Criteria

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

Patients who have had dura mater repair using a Biodesign Dural or Duraplasty Graft.

You may qualify if:

  • \. Planned use of the Biodesign Dural or Duraplasty Graft.

You may not qualify if:

  • Age \<18 years
  • Unable or unwilling to provide informed consent
  • Life expectancy \<6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Alabama Birmingham Hospital

Birmingham, Alabama, 35294, United States

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Ospedale Bellaria-Bolonga

Bologna, 40139, Italy

Location

MeSH Terms

Conditions

Cerebrospinal Fluid LeakCerebrospinal Fluid Otorrhea

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

August 13, 2019

First Posted

August 15, 2019

Study Start

September 3, 2019

Primary Completion

June 6, 2022

Study Completion

September 15, 2022

Last Updated

October 14, 2022

Record last verified: 2022-10

Locations

IT(1)CA(1)US(1)