Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419855
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-09
Brief Title:
Study to Evaluate the Effectivity and Safety of BIOSCAFFH Compared to DuraGen in Patients Undergoing Dural Repair
Sponsor:
Top Health SAPI DE CV
Organization:
Top Health SAPI DE CV
Study Overview
Official Title:
Post-approval Multicenter Study to Evaluate the Efficacy and Safety of BIOSCAFFH a Human Collagen Graft Compared to DuraGen a Bovine-derived Graft in Patients Undergoing Dural Repair Following Cranial Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study in which the presence or absence of symptoms or any health condition is observed and recorded 30 days after a cranial surgery in which the physician places a material or graft either BIOSCAFFH or DuraGen into the skull this material allows the regeneration of tissue that makes up one of the layers of the brain that was affected before or during surgery The primary hypothesis of this study is that there will be no more than a 10 difference in outcomes between the BIOSCAFFH device and the active comparator DuraGen with respect to the incidence of cerebrospinal fluid leak or the presence of pseudomeningocele
Detailed Description:
This study will help describe the safety profile and other aspects such as quality of life of the subjects who received it The primary objective of the study is to evaluate the efficacy of the BIOSCAFF H graft in patients undergoing dural surgery in the absence of cerebrospinal fluid leakage compared to the active comparator
This is a prospective multicenter cohort post-approval study to evaluate the efficacy and safety of BIOSCAFFH It consists of a screening period and a follow-up period up to 52 weeks after surgery Medical records of patients who underwent surgery less than 30 days post-operatively and were implanted with the BIOSCAFFH human collagen dural substitute or the active bovine collagen-based comparator DuraGen will be considered It is estimated that approximately 86 dural surgery patients will be enrolled
This is a prospective multicenter cohort post-approval study to evaluate the efficacy and safety of BIOSCAFFH It consists of a screening period and a follow-up period up to 52 weeks after surgery Medical records of patients who underwent surgery less than 30 days post-operatively and were implanted with the BIOSCAFFH human collagen dural substitute or the active bovine collagen-based comparator DuraGen will be considered It is estimated that approximately 86 dural surgery patients will be enrolled
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None