A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices

Launched by ETHICON ENDO-SURGERY · Aug 31, 2021

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Pediatric population:
• • 1. Non-emergent procedure (general) where at least one vessel is planned to be transected by the HARMONIC 1100 Shears per the IFU;
• • 2. Less than 18 years of age at the time of procedure; and
• • 3. The subject's parent/legal guardian must be willing to give permission for the subject to participate in the study and provide written informed consent for the subject. In addition, assent must be obtained from pediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the study. If the pediatric subject is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the study), the parent/legal guardian's written informed consent for the subject will be acceptable for the subject to be included in the study.
• Adult population:
• • 1. Elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 1100 Shears per the IFU;
• • 2. Willingness to give consent and comply with all study-related evaluations and visit schedule; and
• • 3. At least 18 years of age.
• Exclusion Criteria:
• • Preoperative
• • 1. Physical or psychological condition which would impair study participation;
• • 2. Female subjects, of childbearing age, who are pregnant; or
• • 3. Enrollment in a concurrent interventional clinical study that could impact the study endpoints.
• • Intraoperative
• • 1. The HARMONIC 1100 Shears were not attempted to be used for at least one single vessel transection during the surgical procedure.