Ignite Creation Date:
2024-07-17 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474637
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-20
Brief Title:
Powered Handle Primary Sleeve Gastrectomy Study
Sponsor:
Lexington Medical Inc
Organization:
Lexington Medical Inc
Study Overview
Official Title:
Prospective Clinical Evaluation of the AEON Endoscopic Stapler Powered Handle and Reload in Primary Sleeve Gastrectomy
Status:
RECRUITING
Status Verified Date:
2024-06
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 objective of this prospective single arm single-center study is to evaluate patients who are undergoing primary sleeve gastrectomy procedures and are surgically treated with the AEON Endoscopic Powered Handle Stapler and Stapler Reload The primary endpoint is to assess the percentage of patients who encountered post-operative staple line complications bleeding or leak defined as requiring blood transfusion or revision surgery due to staple line complications
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None