A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures

Last updated: September 11, 2025
Sponsor: Ethicon Endo-Surgery
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

HARMONIC 700 Shears

Clinical Study ID

NCT06608485
ENG202301
ENG202301
  • Ages < 110
  • All Genders

Study Summary

The main purpose of this study is to demonstrate acceptable performance and assess safety of the HARMONIC 700 Shears device in a post-market setting when used per the instructions for use in pediatric and adult surgical procedures.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Pediatric participants

  • Non-emergent procedure (general) where at least one vessel is planned to betransected 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 studyand provide written informed consent for the participant Adult participants

  • Elective procedure (general, gynecological, urological, or thoracic) where at leastone vessel is planned to be transected by the HARMONIC 700 Shears per the IFU

  • Elective procedure (general, gynecological, urological, or thoracic) where at leastone vessel is planned to be transected by the HARMONIC 700 Shears per the IFU

Exclusion

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 studyendpoints Intraoperative

  • HARMONIC 700 Shears were not attempted to be used for at least one single vesseltransection during the surgical procedure

Study Design

Total Participants: 165
Treatment Group(s): 1
Primary Treatment: HARMONIC 700 Shears
Phase:
Study Start date:
January 23, 2025
Estimated Completion Date:
August 15, 2026

Connect with a study center

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec H2X 3E4
    Canada

    Site Not Available

  • Centre Hospitalier de l'Universite de Montreal

    Montreal 6077243, Quebec 6115047 H2X 3E4
    Canada

    Active - Recruiting

  • Dorset County Hospital Nhs Foundation Trust

    Dorchester, DT1 2JY
    United Kingdom

    Site Not Available

  • Dorset County Hospital Nhs Foundation Trust

    Dorchester 2651101, DT1 2JY
    United Kingdom

    Completed

  • Western General Hospital

    Edinburgh, EH4 2XU
    United Kingdom

    Site Not Available

  • Western General Hospital

    Edinburgh 2650225, EH4 2XU
    United Kingdom

    Active - Recruiting

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton 2637487, SO16 6YD
    United Kingdom

    Active - Recruiting

  • Riley Hospital for Children at Indiana University Health

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Riley Hospital for Children at Indiana University Health

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Active - Recruiting

  • NextStage Clinical Research

    Wichita, Kansas 67214
    United States

    Site Not Available

  • NextStage Clinical Research

    Wichita 4281730, Kansas 4273857 67214
    United States

    Site Not Available

  • Icahn School of Medicine at Mt. Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Icahn School of Medicine at Mt. Sinai

    New York 5128581, New York 5128638 10029
    United States

    Active - Recruiting

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • The Methodist Hospital Research Institute D B A Houston Methodist Research Institute

    Houston, Texas 77030
    United States

    Site Not Available

  • The Methodist Hospital Research Institute D B A Houston Methodist Research Institute

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

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