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Reusable surgical clips prove safe and effective in 245-Patient study

NCT ID NCT05363813

Disease control Sponsor: Microline Surgical, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Updated 2 times

Summary

This study looked at a reusable clip system used during laparoscopic (keyhole) surgery to close blood vessels and other tubes. It included 245 adults who had laparoscopic surgery where clips were needed. The main goal was to see if the clips worked well and were safe over 6 months after surgery, by checking for any leaks or problems.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

245 people

The number who actually took part.

Started

Oct 2022

Finished

Aug 2024

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.

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: 1. Adult subjects, male or female, ≥18 years old 2. Subjects who have been scheduled for a laparoscopic surgery using the clip 3. Subjects who had provided written informed consent form 4. Ability and willingness to comply with all study requirements to be evaluated for each study visit Exclusion Criteria: 1. Subjects referred for laparoscopic surgeries to reinforce a staple line or produce partial vessel occlusion 2. Significant surgical contraindications evaluated using the GOALS score 3. Subjects unsuitable for laparoscopic surgery according to PI discretion 4. Subjects who have coagulopathy or uninterruptible anticoagulation therapy 5. Subjects currently under steroid treatment 6. Subject has known allergy to device components (i.e., titanium, stainless steel) 7. Subjects who are participating in another trial which may affect the outcomes data on this study 8. Inability to adhere to study-related procedures 9. Subjects that require emergency surgeries associated with trauma and/or sepsis with a SOFA score ≥ 2 and/or septic shock should be excluded 10. Pregnant or lactating women at the time of the surgery

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As listed by the trial registrant

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

Laparoscopy Leakage of cardiac device Minimally invasive surgical procedures

Contacts and locations

Locations

  • Centro Hospitalar Universitário Lisboa Norte

    Lisbon, Lisbon District, 1649-028, Portugal

  • Complejo Hospitalario Universitario A Coruña del Área Sanitaria de A Coruña y Cee

    A Coruña, A Coruña, 15006, Spain

  • Hospital Quirónsalud Sagrado Corazón

    Seville, Sevilla, 41013, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Hospital Universitario de Salamanca

    Salamanca, Salamanca, 37007, Spain

  • Hospital Universitario y Politécnico La Fe

    Valencia, Valencia, 46026, Spain

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