Acute Cholecystitis Clinical Trial
— AE05MLOfficial 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
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.
Status | Not yet recruiting |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Teleflex |
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 |
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