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

NCT06364865 | Enrolling By Invitation FDA Device

• 1 other identifier: 2022-04
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 3

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 device's safety and performance, with secondary objectives focusing on device performance characteristics and operator feedback.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Evaluating device performance characteristics

  Duration of AE05ML used during laparoscopic procedure

• Evaluating operator reported feedback

  Duration of AE05ML used during laparoscopic procedure

Interventions

laparoscopic procedure DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Imprisoned
• Cognitively impaired and unable to provide informed consent

Sponsors & Collaborators

• Teleflex: lead

Study Sites (3)

Baptist Health South Miami

Miami, Florida, 33143, United States

Location

Northwell Health Long Island Jewish Hospital

New Hyde Park, New York, 11040, United States

Location

New Hanover Regional

Wilmington, North Carolina, 28401, United States

Location

MeSH Terms

Conditions

Gallbladder Diseases; Bile Duct Diseases; Cholecystitis, Acute; Splenic Diseases

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Cholecystitis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Tatiana A Puga, BS

  Teleflex Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 15, 2024
• Study Start: June 7, 2024
• Primary Completion: February 27, 2025
• Study Completion: August 30, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)