Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364865
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-14
First Post:
2024-04-02
Brief Title:
AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study
Sponsor:
Teleflex
Organization:
Teleflex
Study Overview
Official Title:
A Prospective Observational Clinical Registry Study to Assess Safety and Performance of AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures
Status:
ENROLLING_BY_INVITATION
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:
AE05ML
Brief Summary:
This clinical registry study aims to evaluate the safety and effectiveness of the AE05ML device for ligating vessels and tissue structures during laparoscopic surgery using Hem-o-lok Medium Large ML polymer clips The primary objective is to assess the devices safety and performance with secondary objectives focusing on device performance characteristics and operator feedback
Detailed Description:
The objective of this clinical registry study is to evaluate safety and performance of the Weck Auto Endo5 5 mm automatic endoscopic 35 cm applier device Teleflex Incorporated Morrisville NC USA - further referred to as AE05ML for delivery of Hem-o-lok Medium Large ML polymer clips for the purpose of vessel tissue structure ligation in laparoscopic surgery This is a prospective observational multi-center clinical registry study All subjects will undergo vessel tissue structure ligation using AE05ML during their indicated laparoscopic procedure as per standard of care and institutional policy and procedure
The primary objective is to evaluate the safety and performance of AE05ML for delivery of ML Hem-o-lok polymer clips for the purpose of vessel tissue structure ligation in adult subjects during laparoscopic procedures
Primary Endpoints
Safety Incidence of device related adverse events AE
Performance Success Failure of polymer clip delivery attempts The secondary objectives are to evaluate device performance characteristics and operator reported feedback regarding their experience using the device for each case
Secondary Endpoint
Results of Device Performance and Operator Feedback Questionnaire
The primary objective is to evaluate the safety and performance of AE05ML for delivery of ML Hem-o-lok polymer clips for the purpose of vessel tissue structure ligation in adult subjects during laparoscopic procedures
Primary Endpoints
Safety Incidence of device related adverse events AE
Performance Success Failure of polymer clip delivery attempts The secondary objectives are to evaluate device performance characteristics and operator reported feedback regarding their experience using the device for each case
Secondary Endpoint
Results of Device Performance and Operator Feedback Questionnaire
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?:
None