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

Study Overview
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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.

Official Title
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A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears and Generator G11 in Pediatric Surgical Procedures (General) and Adult Surgical Procedures (General, Gynecological, Urological, and Thoracic)

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

Intervention / Treatment
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* Device: HARMONIC 1100 Shears


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric population: Primary laparoscopic 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. Adult population: Primary laparoscopic 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: Preoperative 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. Intraoperative 1. The HARMONIC 1100 Shears were not attempted to be used for at least one single vessel transection during the surgical procedure.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pediatric; adult (HPB, lower gastrointestinal, gastric, gynecological, urological, thoracic)<br>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. | Device: HARMONIC 1100 Shears<br>* HARMONIC 1100 Shears is used for vessel transection according to instructions for use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of vessel transections with an achievement of Grade 3 or lower for each vessel transection based on the scale described below | Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, basic energy devices (monopolar and/or bipolar) and/or touchups with HARMONIC 1100 Shears; or Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with use of additional hemostatic measures (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products). | Intraoperative | 
| Number of Participants with Device-related Adverse Events (AEs) | Number of participants with device-related (possible, probable, or causal) AEs will be reported. An AE is defined as any untoward medical occurrence, regardless of its relationship to the study device or the study procedure. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs throughout the duration of the clinical study. | 2 to 6 weeks postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of 5-point scale scores for sealing and transection of lymphatic vessels completed by HARMONIC 1100 Shears | A 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) will be used to describe how satisfied the surgeon was with the sealing and transection of lymphatic vessels by HARMONIC 1100 Shears. | Intraoperative | 
| The distribution of grades (1-4) seen from the use of the hemostasis grading scale (primary outcome measure) for each vessel transected will be calculated |  | Intraoperative | 
| The number of any additional hemostasis measures required to achieve hemostasis for any Grade 4 vessel transections will be collected |  | Intraoperative |