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

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

Recruiting
110 years and younger
All
Phase N/A
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

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

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

Study details
    Pediatric Surgical Procedures
    Adult Surgical Procedures
    Adult Gynecological Procedures
    Adult Urological Procedures
    Adult Thoracic Procedures

NCT06608485

Ethicon Endo-Surgery

15 October 2025

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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