About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • HARMONIC 700 Shears

Treatment groups

165 Participants
are divided into 1 treatment group

Locations

9
Canada
Centre Hospitalier de l'Universite de MontrealH2X 3E4, MontrealQuebec, Canada
United Kingdom
Dorset County Hospital Nhs Foundation TrustDT1 2JY, Dorchester United Kingdom
Western General HospitalEH4 2XU, Edinburgh United Kingdom
Southampton General HospitalSO16 6YD, Southampton United Kingdom

Sponsors and collaborators

Ethicon Endo-Surgery

Lead sponsor