Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

Study Overview
=================
Brief Summary
-----------------
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade® 4.0 during bilateral breast reduction; to monitor and record post-operative pain, adverse events and skin scarring following surgery; and to compare these outcomes to the HARMONIC SYNERGY® BLADE.

Official Title
-----------------
A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade® 4.0 in Bilateral Breast Reduction

Conditions
-----------------
Macromastia (Symptomatic)

Intervention / Treatment
-----------------
* Device: PEAK PlasmaBlade
* Procedure: Scalpel and Traditional Electrosurgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 70 Physically healthy, stable weight No smoking <1 month prior to surgery and during study. Desiring bilateral breast reduction Subject must understand the nature of the procedure and provide written informed consent prior to the procedure. Subject must be willing and able to comply with specified follow-up evaluations. Female subjects must either be incapable of reproduction, or taking acceptable measures to prevent pregnancy and have a negative pregnancy test prior to participation in the study. Exclusion Criteria: Age younger than 18 or greater than 70 years old Anticoagulation therapy which cannot be discontinued Smoking <1 month prior to surgery or during study Infection (local or systemic) Cognitive impairment or mental illness Severe cardiopulmonary deficiencies Known coagulopathy Immunocompromised Prior history of breast cancer Kidney disease (any type) Currently taking any medication known to affect healing Subjects who are status-post gastric banding or gastric bypass Currently enrolled in another investigational device or drug trial Unable to follow instructions or complete follow-up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEAK PlasmaBlade<br> | Device: PEAK PlasmaBlade<br> <br> |
| Active Comparator: Standard of Care<br>The Standard of Care arm will consist of the scalpel for the skin incision and traditional electrosurgery for subcutaneous dissection. | Procedure: Scalpel and Traditional Electrosurgery<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in pain | The primary endpoint will be the difference in pain between the Harmonic and PlasmaBlade operative sites. The primary efficacy variable will be pain at each treatment arm operative site, as measured by visual analog scale for 24 hours post-operatively and for 10 post-op days twice daily. | 24 hours and first 10 days post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative performance | Dissection time (normalized), estimated blood loss, use of traditional device for bleeding control, volume of tissue resection. | Intraoperatively on day 0 | 
| Adverse events | Monitoring for adverse events following surgery, including hematoma, seroma, wound dehiscence, etc. | 1 month post-operatively | 
| Cutaneous scarring | Scar width, quality, pigmentation, elevation, nodularity, thickness, and cosmetic appearance will be blindly evaluated by subject and independent observers. | Up to one year post-operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reduction mammaplasty, Breast reduction, PlasmaBlade, PEAK