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AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study
Sponsor: Teleflex
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
161
Start Date
2024-06-07
Completion Date
2025-08-30
Last Updated
2025-08-05
Healthy Volunteers
No
Conditions
Interventions
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 (3)
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