Ignite Creation Date:
2025-12-18 @ 9:49 AM
Ignite Modification Date:
2025-12-23 @ 10:30 PM
Study NCT ID:
NCT03820713
Status:
None
Last Update Posted:
2020-07-23 00:00:00
First Post:
2018-08-12 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Feasibility, Safety, Initial Efficacy and Clinical Usability of FuseX Anti-Adhesion System
Sponsor:
None
Organization:
Study Overview
Official Title:
Prospective, Randomized, Double Blinded, Parallel, Controlled, Two-arm, Two-center Evaluation of the Feasibility, Safety, Initial Efficacy and Clinical Usability of FuseX Anti-Adhesion System
Status:
None
Status Verified Date:
2020-07
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:
Evaluation of the feasibility, safety, initial efficacy and usability of FuseX Anti-Adhesion system toward further studies that will be powered to proved its safety and efficacy. In addition, this initial study will serve to yield blood bank and surgeon feedback towards improving the system.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: