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Completed

Age: 0 - 110Years
All Genders
ID06608485

A Prospective, Single-Arm Multi-Center Study of the HARMONIC 700, 5 mm Diameter Shears With Advanced Hemostasis in Pediatric Surgical Procedures General and Adult Surgical Procedures General, Gynecological, Urological, and Thoracic

Led by Ethicon Endo-Surgery · Updated on 2026-08-03

173

Participants Needed

7

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 110Years
All Genders

Eligibility Criteria

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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