Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-02-28 @ 10:56 PM
Study NCT ID:
NCT03654560
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2018-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting
Sponsor:
United Health Products, Inc.
Organization:
Study Overview
Official Title:
Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting
Status:
COMPLETED
Status Verified Date:
2019-10
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 the study is to assess efficacy and safety of HemoStyp as an adjunct for management of secondary hemostasis in the operative setting.
Detailed Description:
This study is a prospective, non-inferiority, multi-center, randomized, open-label trial to compare HemoStyp with Surgicel® in the management of bleeding during surgery.
Study Oversight
Has Oversight DMC:
None
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?: