A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures

Ethicon

Status: Enrolling

Conditions: Adult Surgical Procedures; Adult Urological Procedures; Adult Thoracic Procedures; Adult Gynecological Procedures; Pediatric Surgical Procedures

Treatments: Device: HARMONIC 700 Shears

Study type: Observational

Funder types: Industry

Identifiers

NCT06608485

ENG202301

Details and patient eligibility

About

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.

Enrollment: 165 estimated patients

Sex: All

Ages: Under 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

165 participants in 1 patient group

Pediatric; Adult Surgical Procedures (HARMONIC 700 Shears)

Description:

This prospective study will involve collection of clinical data in a post-market setting from pediatric surgical procedures (general) and adult surgical procedures (general, gynecological, urological, and thoracic surgical procedures). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the HARMONIC 700 Shears instruction for use (IFU). All subjects enrolled will be followed post-operatively through discharge and again at approximately 28 days post-surgery.

Treatment:

Device: HARMONIC 700 Shears