Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-24 @ 5:07 PM
Study NCT ID:
NCT04471350
Status:
WITHDRAWN
Last Update Posted:
2021-08-30
First Post:
2020-07-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-market Evaluation of HEMOBLAST™ Bellows in Spine Surgery
Sponsor:
Biom'Up France SAS
Organization:
Study Overview
Official Title:
Post-market Evaluation of HEMOBLAST™ Bellows Performance and Safety in Spine Surgery
Status:
WITHDRAWN
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Indication withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective, multi-center, multi-national post-market study evaluating the performance and safety HEMOBLAST™ Bellows in spine surgery
Detailed Description:
Prospective, multi-center, multi-national post-market study evaluating the performance and safety HEMOBLAST™ Bellows in spine surgery. Up to 80 subjects will be enrolled at up to 6 sites.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: