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NCT04057157 Clinical Trial

Post-market Assessment of Biodesign Dural Repair Grafts

Cerebrospinal Fluid Leak Clinical Trial

Official title:
Post-market Clinical Data Collection Plan for the Biodesign® Dural and Duraplasty Grafts

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04057157
Other study ID # 17-10
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 3, 2019
Est. completion date September 15, 2022

Study information
Verified date October 2022
Source Cook Group Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 128
Est. completion date September 15, 2022
Est. primary completion date June 6, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Planned use of the Biodesign Dural or Duraplasty Graft. Exclusion Criteria: 1. Age <18 years 2. Unable or unwilling to provide informed consent 3. Life expectancy <6 months

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Canada Toronto Western Hospital Toronto Ontario
Italy Ospedale Bellaria-Bolonga Bologna
United States University of Alabama Birmingham Hospital Birmingham Alabama

Sponsors (1)
Lead Sponsor Collaborator
Cook Research Incorporated

Countries where clinical trial is conducted

United States,  Canada,  Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
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Recruiting NCT02927782 - Mobilisation Algorithm After Incidental Durotomy N/A
Completed NCT03566602 - Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery N/A
Completed NCT02891070 - Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery Phase 3
Recruiting NCT04490629 - The Efficacy and Safety of a Latest Dural Substitute N/A
Withdrawn NCT04351061 - Acetazolamide for the Prevention of Post Operative CSF Leak Phase 2
Recruiting NCT04086550 - Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery N/A
Completed NCT02457546 - The EVICEL® Neurosurgery Phase III Study Phase 3
Completed NCT04145544 - A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes. To Evaluate the Safety and Effectiveness of ArtiFascia® in Subjects Requiring Dural Repair. N/A
Completed NCT04124523 - Perioperative CSF Leak Management - an Opinion Study
Active, not recruiting NCT04923867 - Suturable DuraGen™ PMCF Study
Withdrawn NCT03181464 - Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics Phase 4