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

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

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.

Study Overview

• Status: Completed
• Conditions: Bile Duct Diseases; Acute Cholecystitis; Liver; Gall Bladder Disease; Prostate; Kidney; Appendix; Spleen Disease
• Intervention / Treatment: Device: laparoscopic procedure

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

• Study Type: Observational
• Enrollment (Actual): 161

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33143
      • Baptist Health South Miami
  • New York
    • New Hyde Park, New York, United States, 11040
      • Northwell Health Long Island Jewish Hospital
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • New Hanover Regional

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo laparoscopic procedures for which AE05ML is planned for use for delivery of ML Hem-o-lok polymer clips for ligation of vessels / tissue structures 3 - 10 mm in size, per the device instructions for use (IFU), should be considered for participation in the study. One hundred sixty-one (161) evaluable adult subjects are required. An evaluable subject is defined as a subject in whom clip delivery via AE05ML was attempted, during their scheduled laparoscopic procedure, in accordance with the device IFU, and the Laparoscopic Procedure Data Collection was performed. Additional subjects will be recruited to replace non-evaluable subjects to meet the target sample size. Reasons for determining a subject to be non-evaluable will be documented.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluating the safety of AE05ML	The primary objective is to evaluate the safety (Incidence of device related adverse events (AE)) 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.	Duration of AE05ML used during laparoscopic procedure
Evaluating the performance of AE05ML	The primary objective is to evaluate the performance (Success / Failure of polymer clip delivery attempts) 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.	Duration of AE05ML used during laparoscopic procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluating device performance characteristics	The secondary objectives are to evaluate device performance characteristics of the AE05ML device during laparoscopic procedures by evaluating user reported feed back from user questionnaires.	Duration of AE05ML used during laparoscopic procedure
Evaluating operator reported feedback	The secondary objectives are to evaluate operator reported feedback, on questionnaires, regarding their experience using the device for each case.	Duration of AE05ML used during laparoscopic procedure

Collaborators and Investigators

• Sponsor: Teleflex
• Investigators: Study Director: Tatiana A Puga, BS, Teleflex Inc

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2024
• Primary Completion (Actual): February 27, 2025
• Study Completion (Actual): August 30, 2025

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Cholecystitis; Gallbladder Diseases; Cholecystitis, Acute; Bile Duct Diseases; Splenic Diseases; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy; Laparoscopy
• Other Study ID Numbers: 2022-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No