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)
Ethicon Endo-Surgery
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
- Age range
- Up to 110 years
- Sex
- All
- Healthy volunteers
- No
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, u…
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 HealthIndianapolis, Indiana
- NextStage Clinical ResearchWichita, Kansas
- Icahn School of Medicine at Mt. SinaiNew York, New York
- The Methodist Hospital Research Institute D B A Houston Methodist Research InstituteHouston, Texas
- Centre Hospitalier de l'Universite de MontrealMontreal, Quebec
- Dorset County Hospital Nhs Foundation TrustDorchester