CompletedNot Applicable

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

United States, Canada265 participantsStarted 2021-07-29

Plain-language summary

This prospective, single-arm, multi-center study will collect clinical data in a post-market setting for the pediatric population (general surgical procedures) and adult population (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 1100 Shears and Generator G11 instructions for use.

Who can participate

SexALL

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Inclusion criteria

✓. Non-emergent procedure (general) where at least one vessel is planned to be transected by the HARMONIC 1100 Shears per the IFU;
✓. Less than 18 years of age at the time of procedure; and
✓. 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.
✓. 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;
✓. Willingness to give consent and comply with all study-related evaluations and visit schedule; and
✓. At least 18 years of age.

Exclusion criteria

✕. Physical or psychological condition which would impair study participation;
✕. Female subjects, of childbearing age, who are pregnant; or
✕. Enrollment in a concurrent interventional clinical study that could impact the study endpoints.

What they're measuring

Number of Vessels Transected With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale

Timeframe: On the day of transection (Day 0)

Number of Participants With Device-related Adverse Events (AEs)

Timeframe: From Day 0 up to post-procedure follow up visit (up to 28 days)

Trial details

NCT IDNCT05039021

SponsorEthicon Endo-Surgery

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-04

Results submitted2025-01-27

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