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

Ethicon

Status: Completed

Conditions: Adult Urological Procedures; Adult Hepato-pancreato-biliary (HPB) Procedures; Pediatric Procedures; Adult Thoracic Procedures; Adult Gynecological Procedures; Adult Lower Gastrointestinal Procedures; Adult Gastric Procedures

Treatments: Device: HARMONIC 1100 Shears

Study type: Interventional

Funder types: Industry

Identifiers

NCT05039021

ENG_2020_06

Details and patient eligibility

About

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.

Enrollment: 265 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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265 participants in 1 patient group

Pediatric; adult (HPB, lower gastrointestinal, gastric, gynecological, urological, thoracic)

Experimental group

Description:

Any pediatric or adult (hepato-pancreato-biliary, lower gastrointestinal, gastric, gynecological, urological, thoracic) procedures where the HARMONIC 1100 Shears is used for vessel transection according to instructions for use.

Treatment:

Device: HARMONIC 1100 Shears