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

Completed

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

In brief

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.

Key facts

Study ID

NCT06364865

Run by

Teleflex

People needed

161

Starts

2024-06-07

Expected to finish

2025-08-30

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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, United States

Full record on ClinicalTrials.gov

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