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

Launched by ETHICON ENDO-SURGERY · Sep 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medical tool called the HARMONIC 700 Shears, which is used in various types of surgeries for both children and adults. The main goal of the study is to see how well this device works and how safe it is when used according to the instructions during surgeries that involve cutting blood vessels. The trial is currently looking for participants, including both pediatric patients (under 18) and adults undergoing elective surgeries in areas like gynecology, urology, and thoracic procedures.

To qualify for the trial, pediatric participants must be scheduled for a non-emergency surgery where the HARMONIC 700 Shears will be used to cut at least one blood vessel, and their parent or guardian needs to give permission. Adult participants must also have a scheduled elective surgery involving a similar procedure. During the trial, participants can expect to have their safety and the effectiveness of the shears monitored closely by the study team. It’s important to know that those with certain health conditions or who are pregnant cannot participate, and the study is focused on surgeries where the shears are actually used to cut a blood vessel.

Gender

ALL

Eligibility 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, 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