NCT06364865

AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study

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
• Phase: —
• Study type: Observational
• Enrollment: 161 (estimated)
• Sponsor: Teleflex · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 device's 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

Conditions

• Gall Bladder Disease
• Bile Duct Diseases
• Acute Cholecystitis
• Kidney
• Liver
• Appendix
• Spleen Disease
• Prostate

Interventions

Type	Name	Description
DEVICE	laparoscopic procedure	Not applicable, subject requiring procedure will have a laparoscopic procedure performed according to the institutions standard of care procedures. There are no clinical procedures performed on the subject as part of this registry study. Surgeon will answer questionnaires regarding use of the device upon completion of the laparoscopic procedure.

Timeline

• Start date: 2024-06-07
• Primary completion: 2025-02-27
• Completion: 2025-08-30
• First posted: 2024-04-15
• Last updated: 2025-08-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study