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
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