Acute Cholecystitis, Appendix, Bile Duct Diseases, Gall Bladder Disease, Kidney, Liver, Prostate, Spleen Disease
Conditions
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.
Detailed description
The objective of this clinical registry study is to evaluate safety and performance of the Weck® Auto Endo5® 5 mm automatic endoscopic 35 cm applier device (Teleflex Incorporated, Morrisville, NC, USA - further referred to as AE05ML) for delivery of Hem-o-lok® Medium Large (ML) polymer clips for the purpose of vessel / tissue structure ligation in laparoscopic surgery. This is a prospective, observational, multi-center, clinical registry study. All subjects will undergo vessel / tissue structure ligation using AE05ML during their indicated laparoscopic procedure as per standard of care and institutional policy and procedure. The primary objective is to evaluate the safety and performance 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. Primary Endpoints * Safety: Incidence of device related adverse events (AE) * Performance: Success / Failure of polymer clip delivery attempts The secondary objectives are to evaluate device performance characteristics and operator reported feedback regarding their experience using the device for each case. Secondary Endpoint • Results of Device Performance and Operator Feedback Questionnaire
Interventions
DEVICElaparoscopic 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.
Sponsors
Teleflex
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluating the safety of AE05ML | Duration of AE05ML used during laparoscopic procedure | 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. |
| Evaluating the performance of AE05ML | Duration of AE05ML used during laparoscopic procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluating device performance characteristics | Duration of AE05ML used during laparoscopic procedure | 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. |
| Evaluating operator reported feedback | Duration of AE05ML used during laparoscopic procedure | The secondary objectives are to evaluate operator reported feedback, on questionnaires, regarding their experience using the device for each case. |
Countries
United States
Contacts
STUDY_DIRECTORTatiana A Puga, BS
Teleflex Inc
Outcome results
None listed