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

Last updated: March 27, 2025
Sponsor: Ethicon Endo-Surgery
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

HARMONIC 1100 Shears

Clinical Study ID

NCT05039021
ENG_2020_06
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Pediatric population:

  1. Non-emergent procedure (general) where at least one vessel is planned to betransected 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 thesubject to participate in the study and provide written informed consent for thesubject. In addition, assent must be obtained from pediatric subjects who possessthe intellectual and emotional ability to comprehend the concepts involved in thestudy. If the pediatric subject is not able to provide assent (due to age, maturityand/or inability to intellectually and/or emotionally comprehend the study), theparent/legal guardian's written informed consent for the subject will be acceptablefor the subject to be included in the study.

Adult population:

  1. Elective procedure (general, gynecological, urological, or thoracic) where at leastone 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 visitschedule; and

  3. At least 18 years of age.

Exclusion

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 studyendpoints.

Intraoperative

  1. The HARMONIC 1100 Shears were not attempted to be used for at least one singlevessel transection during the surgical procedure.

Study Design

Total Participants: 265
Treatment Group(s): 1
Primary Treatment: HARMONIC 1100 Shears
Phase:
Study Start date:
July 29, 2021
Estimated Completion Date:
March 12, 2024

Connect with a study center

  • Centre Hospitalier de l'Universite de Montreal

    Montreal,
    Canada

    Site Not Available

  • Toronto General Hospital

    Toronto,
    Canada

    Site Not Available

  • Western General Hospital

    Edinburgh, Scotland
    United Kingdom

    Site Not Available

  • Baptist Health

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • IU Health University Hospital

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Riley Hospital for Children at Indiana University Health

    Indianapolis, Indiana 46202
    United States

    Site Not Available

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