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NCT06608485Recruiting

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

Ethicon Endo-Surgery

Start Date

1/23/2025

Completion Date

8/15/2026

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

Age Range: No minimum to 110 years

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

Interventions

DEVICE

HARMONIC 700 Shears

Interested in This Trial?

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Conditions

Pediatric Surgical ProceduresAdult Surgical ProceduresAdult Gynecological ProceduresAdult Urological ProceduresAdult Thoracic Procedures

Locations

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana 46202

United States

NextStage Clinical Research

Wichita, Kansas 67214

United States

Icahn School of Medicine at Mt. Sinai

New York, New York 10029

United States

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

Houston, Texas 77030

United States

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec H2X 3E4

Canada

Dorset County Hospital Nhs Foundation Trust

Dorchester, DT1 2JY

United Kingdom

Western General Hospital

Edinburgh, EH4 2XU

United Kingdom

Southampton General Hospital

Southampton, SO16 6YD

United Kingdom

Yeovil District Hospital

Yeovil, BA214AT

United Kingdom