An observational study in Gall Bladder Disease, Bile Duct Diseases and Acute Cholecystitis, sponsored by Teleflex. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Teleflex · Observational
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
140 studies on the registry are indexed under Cholecystitis, Acute; 30 are open to participants now.
This study's enrollment of 161 is below the median of 216 across 52 observational studies indexed under Cholecystitis, Acute.
Browse Cholecystitis, Acute studies →Teleflex is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
Compared within Cholecystitis, Acute, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Gallbladder Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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.
Time frame: Duration of AE05ML used during laparoscopic procedure
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.
Time frame: Duration of AE05ML used during laparoscopic procedure
Evaluating operator reported feedback
The secondary objectives are to evaluate operator reported feedback, on questionnaires, regarding their experience using the device for each case.
Time frame: Duration of AE05ML used during laparoscopic procedure
Plan to share: No — Data will not be shared
No publications or documents are linked to this record.
Ran from Jun 2024 to primary completion in Feb 2025, 8 months.
Of 22 observational studies under Cholecystitis, Acute, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 42. This study's 8 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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