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New surgical clip tool tested in 161 patients

NCT ID NCT06364865

Knowledge-focused Sponsor: Teleflex Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at a new device called AE05ML that helps surgeons place clips on blood vessels and other tissues during keyhole surgery. The goal was to see if the device is safe and works well. A total of 161 adults took part in the study.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

161 people

The number who actually took part.

Started

Jun 2024

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute cholecystitis bile duct disorder gallbladder disorder kidney disorder liver disorder prostate cancer splenic disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute cholecystitis Appendix Bile duct diseases Gall bladder disease KIDNEY LIVER Prostate Spleen disease

Contacts and locations

Locations

  • Baptist Health South Miami

    Miami, Florida, 33143, United States

  • New Hanover Regional

    Wilmington, North Carolina, 28401, United States

  • Northwell Health Long Island Jewish Hospital

    New Hyde Park, New York, 11040, United States

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