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

Detailed criteria

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

Device

Locations (9)

Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana
NextStage Clinical Research
Wichita, Kansas
Icahn School of Medicine at Mt. Sinai
New York, New York
The Methodist Hospital Research Institute D B A Houston Methodist Research Institute
Houston, Texas
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec
Dorset County Hospital Nhs Foundation Trust
Dorchester