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New surgical tool tested for safety in kids and adults

NCT ID NCT06608485

Disease control Sponsor: Ethicon Endo-Surgery 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 04, 2026 · Updated 2 times

Summary

This study is testing the HARMONIC 700 Shears, a device that cuts and seals blood vessels during surgery, in 165 children and adults. The goal is to see how well it controls bleeding and if it causes any side effects. Participants will have planned surgeries where the device is used as intended.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HARMONIC 700 Shears (surgical device)
What this could lead to
If successful, this study could confirm that the HARMONIC 700 shears are safe and effective for use in a wide range of pediatric and adult surgeries.
What could go wrong
This is a post-market study with no control group, so results may not prove superiority over other devices. Risks include device-related adverse events like bleeding or tissue damage.

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

173 people

The number who actually took part.

Started

Jan 2025

Finished

Jun 2026

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

The study population will include pediatric participants aged less than (\<) 18 years of age and adult participants of at least 18 years of age in whom at least one vessel is planned to be transected by the HARMONIC 700 Shears as per the instructions for use (IFU).

Ages

Up to 110 years

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: Pediatric participants * Non-emergent procedure (general) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU * Less than 18 years of age at the time of procedure * Participant's parent/legal guardian must give permission to participate in the study and provide written informed consent for the participant Adult participants * Elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU * Elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU Exclusion Criteria: Preoperative * Physical or psychological condition which would impair study participation * Participants of childbearing potential who are pregnant * Enrollment in a concurrent interventional clinical study that could impact the study endpoints Intraoperative * HARMONIC 700 Shears were not attempted to be used for at least one single vessel transection during the surgical procedure

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As listed by the trial registrant

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

Adult gynecological procedures Adult surgical procedures Adult thoracic procedures Adult urological procedures Pediatric surgical procedures

Contacts and locations

Locations

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4, Canada

  • Dorset County Hospital Nhs Foundation Trust

    Dorchester, DT1 2JY, United Kingdom

  • Icahn School of Medicine at Mt. Sinai

    New York, New York, 10029, United States

  • Riley Hospital for Children at Indiana University Health

    Indianapolis, Indiana, 46202, United States

  • Southampton General Hospital

    Southampton, SO16 6YD, United Kingdom

  • Western General Hospital

    Edinburgh, EH4 2XU, United Kingdom

  • Yeovil District Hospital

    Yeovil, BA214AT, United Kingdom

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