By InvitationNot Applicable

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

United States161 participantsStarted 2024-06-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Evaluating the safety of AE05ML

Timeframe: Duration of AE05ML used during laparoscopic procedure

Evaluating the performance of AE05ML

Timeframe: Duration of AE05ML used during laparoscopic procedure

Trial details

NCT IDNCT06364865

SponsorTeleflex

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-02-27

View on ClinicalTrials.gov More Gall Bladder Disease trials