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

Teleflex

Status: Invitation-only

Conditions: Appendix; Kidney; Prostate; Bile Duct Diseases; Gall Bladder Disease; Spleen Disease; Liver; Acute Cholecystitis

Treatments: Device: laparoscopic procedure

Study type: Observational

Funder types: Industry

Identifiers

NCT06364865

2022-04

Details and patient eligibility

About

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.

Full 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

Enrollment: 161 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older
• Scheduled for a laparoscopic procedure in which AE05ML will be used for vessel / tissue structure ligation
• Capable of providing informed consent for participation

Exclusion criteria

• Imprisoned
• Cognitively impaired and unable to provide informed consent