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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-29

Study Completion Date

2024-03-12

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

HARMONIC 1100 Shears

Intervention Type DEVICE

HARMONIC 1100 Shears is used for vessel transection according to instructions for use.

Interventions

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HARMONIC 1100 Shears

HARMONIC 1100 Shears is used for vessel transection according to instructions for use.

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No