Clinical trial NCT06364865: AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Gall Bladder Disease
Bile Duct Diseases
Acute Cholecystitis
Kidney
Liver
Appendix
Spleen Disease
Prostate
Lead sponsor: Teleflex
Sponsor class: INDUSTRY
First posted: 2024-04-15
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Evaluating the safety of AE05ML
timeFrame: Duration of AE05ML used during laparoscopic procedure
measure: Evaluating the performance of AE05ML
timeFrame: Duration of AE05ML used during laparoscopic procedure
Secondary outcomes:
measure: Evaluating device performance characteristics
timeFrame: Duration of AE05ML used during laparoscopic procedure
measure: Evaluating operator reported feedback
timeFrame: Duration of AE05ML used during laparoscopic procedure
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Health South Miami
state: Florida
city: New Hyde Park
country: United States
facility: Northwell Health Long Island Jewish Hospital
state: New York
city: Wilmington
country: United States
facility: New Hanover Regional
state: North Carolina
Study officials:
affiliation: Teleflex Inc
name: Tatiana A Puga, BS
role: STUDY_DIRECTOR
References: