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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.
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
Secondary Endpoint
• Results of Device Performance and Operator Feedback Questionnaire
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic procedure | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Evaluating operator reported feedback |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled to undergo laparoscopic procedures for which AE05ML is planned for use for delivery of ML Hem-o-lok polymer clips for ligation of vessels / tissue structures 3 - 10 mm in size, per the device instructions for use (IFU), should be considered for participation in the study. One hundred sixty-one (161) evaluable adult subjects are required. An evaluable subject is defined as a subject in whom clip delivery via AE05ML was attempted, during their scheduled laparoscopic procedure, in accordance with the device IFU, and the Laparoscopic Procedure Data Collection was performed. Additional subjects will be recruited to replace non-evaluable subjects to meet the target sample size. Reasons for determining a subject to be non-evaluable will be documented.
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| Name | Affiliation | Role |
|---|---|---|
| Tatiana A Puga, BS | Teleflex Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Health South Miami | Miami | Florida | 33143 | United States | ||
| Northwell Health Long Island Jewish Hospital |
Data will not be shared
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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 |
| New Hyde Park |
| New York |
| 11040 |
| United States |
| New Hanover Regional | Wilmington | North Carolina | 28401 | United States |
| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D001649 | Bile Duct Diseases |
| D041881 | Cholecystitis, Acute |
| D013158 | Splenic Diseases |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D002764 | Cholecystitis |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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