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A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures
Sponsor: 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.
Official title: 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)
Key Details
Gender
All
Age Range
Any - 110 Years
Study Type
OBSERVATIONAL
Enrollment
165
Start Date
2025-01-23
Completion Date
2026-08-15
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
HARMONIC 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