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

Acute Cholecystitis Clinical Trial

— AE05ML  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06364865
• Other study ID #: 2022-04
• Status: Enrolling by invitation
• Start date: June 7, 2024
• Est. completion date: March 30, 2025

Study information

• Verified date: April 2024
• Source: Teleflex
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 161
• Est. completion date: March 30, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Cholecystitis
• Appendix
• Bile Duct Diseases
• Cholecystitis
• Cholecystitis, Acute
• Gall Bladder Disease
• Gallbladder Diseases
• Kidney
• Liver
• Prostate
• Urinary Bladder Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Baptist Health South Miami	Miami	Florida
United States	Northwell Health Long Island Jewish Hospital	New Hyde Park	New York
United States	New Hanover Regional	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Teleflex

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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