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RecruitingNCT06608485

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

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)

Sponsor

Ethicon Endo-Surgery

Enrollment

165 participants

Start Date

Jan 23, 2025

Study Type

OBSERVATIONAL

Conditions

Pediatric Surgical ProceduresAdult Surgical ProceduresAdult Gynecological ProceduresAdult Urological ProceduresAdult Thoracic Procedures

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

Max Age: 110 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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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Interventions

DEVICEHARMONIC 700 Shears

There is no intervention, beyond necessary clinical care, in this study. HARMONIC 700 Shears for vessel transection were used according to instructions for use.

Locations(9)

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, United States

NextStage Clinical Research

Wichita, Kansas, United States

Icahn School of Medicine at Mt. Sinai

New York, New York, United States

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

Houston, Texas, United States

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Dorset County Hospital Nhs Foundation Trust

Dorchester, United Kingdom

Western General Hospital

Edinburgh, United Kingdom

Southampton General Hospital

Southampton, United Kingdom

Yeovil District Hospital

Yeovil, United Kingdom

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NCT06608485