Ignite Creation Date:
2025-12-24 @ 1:47 PM
Ignite Modification Date:
2025-12-27 @ 9:53 PM
Study NCT ID:
NCT03770195
Status:
WITHDRAWN
Last Update Posted:
2018-12-14
First Post:
2018-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty
Sponsor:
Biom'Up France SAS
Organization:
Study Overview
Official Title:
Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty
Status:
WITHDRAWN
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
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 post-market observational registry is to collect additional data on the safety and efficacy of the HEMOBLAST™ Bellows device in abdominoplasty procedures.
Detailed Description:
A maximum of 100 subjects will be enrolled at up to 5 centers in the United States.
Enrollment occurs intraoperatively after confirmation of eligibility criteria. Data collection will occur during the surgical procedure as well as during patient follow up and will follow site standard of care. Subjects will be discontinued from the study after completion of the final follow up visit. The estimated duration of the study is approximately 6 months from the time of first subject enrollment to completion of the last subject follow up.
Enrollment occurs intraoperatively after confirmation of eligibility criteria. Data collection will occur during the surgical procedure as well as during patient follow up and will follow site standard of care. Subjects will be discontinued from the study after completion of the final follow up visit. The estimated duration of the study is approximately 6 months from the time of first subject enrollment to completion of the last subject follow up.
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?: