Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-29 @ 4:10 PM
Study NCT ID:
NCT04734535
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2021-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery
Sponsor:
Dilon Technologies Inc.
Organization:
Study Overview
Official Title:
Prospective, Randomized, Controlled, Multicenter, Clinical Investigation Evaluating the Safety of HEMOBLAST™ Bellows in Spine Surgery
Status:
COMPLETED
Status Verified Date:
2024-04
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:
The purpose of this clinical investigation in open, elective, spine surgery is to collect data to support the removal of the neurosurgical exclusion from the currently approved indication for the use of HEMOBLAST™ Bellows. This study is primarily designed to assess safety of the device for use in spine surgery, although efficacy information will also be captured and reported.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: