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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 110
SponsorEthicon Endo-Surgery

About this trial

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

Qualifiers

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

Disqualifiers

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

Treatments tested in this trial

  • HARMONIC 700 Shears

Treatment groups

165 Participants
are divided into 1 treatment group

Sponsors and collaborators