Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery

Study Overview
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Brief Summary
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This is a prospective, multi-center, single-blinded, randomized study of up to 10 study subjects undergoing bilateral gynecomastia surgery with Renuvion APR System used as an adjunct procedure on one side. The study will be conducted at up to 3 investigational centers in the United States.

Detailed Description
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This is a prospective, multi-center, single-blinded, randomized study of up to 10 study subjects undergoing bilateral gynecomastia surgery with Renuvion APR System used as an adjunct procedure on one side. The study will be conducted at up to 3 investigational centers in the United States. At baseline, the grade of gynecomastia will be recorded by side, male chest measurements will be taken, and pre-surgery photographs taken in the frontal, lateral, and oblique views. The gynecomastia surgery and Renuvion APR System use will be as per investigator's standard clinical practice. During the procedure, fat transfer and treatment of the lateral chest and/or axilla is not allowed. The Renuvion APR System will be used on one side only. The treated side will be randomized and the patient will be blinded as to which side of the chest received Renuvion. Procedure data and adverse events will be captured. Endermology is not allowed post-procedure. Post-procedure compression will be used for 2-3 weeks with a standard compression vest for all subjects. Follow-up images, grade of gynecomastia, and male chest measurements will be taken at D30/D90/D180. All images will be assessed for correct identification of Renuvion-treated side by blinded Independent Photographic Reviewers (IPR) following the D180 visit. Following study participation, the subject will be offered an optional balancing treatment to the side not previously treated with Renuvion.

Official Title
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A Pilot Study of the Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery

Conditions
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Gynecomastia

Intervention / Treatment
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* Device: Renuvion APR System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects, ages 18 - 75 years old. ASA Physical Status Classification System Class I and Class II subjects. Clinical diagnosis of primary or secondary Gynecomastia. Gynecomastia Rohrich Grade IIA or higher. Symmetrical gynecomastia Rohrich grades. Symmetrical chest measurements (no more than 3% variance between sides). Scheduled for Gynecomastia surgery. Willing to have Renuvion APR System as an adjunct procedure on one side understanding that an optional balancing procedure may be provided post-study exit. Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation. Absence of physical conditions unacceptable to the investigator. Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits. Willing to release rights for the use of study photos, including in publication. Able to read, understand, sign, and date the informed consent. Exclusion Criteria: Subjects without clinical diagnosis of primary Gynecomastia and/or a clinical diagnosis of gynecomastia with secondary causes such as medications, drugs, or testicular tumors. Subjects presenting with ASA Physical Status Classification System Classes III or higher. Gynecomastia Rohrich Grade I. Non-symmetrical gynecomastia Rohrich grades. Non-symmetrical chest measurements (more than 3% variance between sides). Previous treatment or surgery in the breast area. Active systemic or local skin disease that may alter wound healing. Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health. History of autoimmune disease (excluding Hashimoto's thyroiditis). Known susceptibility to keloid formation or hypertrophic scarring. Cancerous or pre-cancerous lesions in the area to be treated. Possesses a surgically implanted electronic device (i.e. pacemaker). Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years. Use of endermology post-procedure for the duration of the study. Participation in any other investigational study within 30 days prior to consent and throughout study participation. Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bilateral gynecomastia surgery with Renuvion APR System right side<br>The gynecomastia surgery and Renuvion APR System use will be as per investigator's standard clinical practice. The Renuvion APR System will be used on the right side only. The treated side will be randomized and the patient and Independent Reviewer will be blinded as to which side of the chest received Renuvion. | Device: Renuvion APR System<br>* The Renuvion APR Handpiece (K191542) is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. The Renuvion APR Handpiece is compatible with the Electrosurgical Generators BVX-200H/P (K170188), and APYX-JS3/RS3 (K192867) owned by Apyx Medical that are indicated for delivery of radiofrequency energy and/or helium gas plasma to cut, coagulate, and ablate soft tissue during open and laparoscopic surgical procedures.<br>|
| Active Comparator: Bilateral gynecomastia surgery with Renuvion APR System left side<br>The gynecomastia surgery and Renuvion APR System use will be as per investigator's standard clinical practice. The Renuvion APR System will be used on the left side only. The treated side will be randomized and the patient and Independent Reviewer will be blinded as to which side of the chest received Renuvion. | Device: Renuvion APR System<br>* The Renuvion APR Handpiece (K191542) is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. The Renuvion APR Handpiece is compatible with the Electrosurgical Generators BVX-200H/P (K170188), and APYX-JS3/RS3 (K192867) owned by Apyx Medical that are indicated for delivery of radiofrequency energy and/or helium gas plasma to cut, coagulate, and ablate soft tissue during open and laparoscopic surgical procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of bilateral occurrence of adverse events | Analysis of bilateral occurrence of adverse events | Through Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bilateral analysis of change to Soft-Tissue Pinch Thickness of the Upper Pole | A measurement of the soft-tissue pinch thickness of the upper pole, by isolating skin and subcutaneous tissue superior to the breast parenchyma, pinching firmly, and measuring the thickness with a caliper. | Day 30, 90, 180 | 
| Bilateral analysis of change to Soft-Tissue Pinch Thickness at the Inframammary Fold | A measurement of soft-tissue pinch thickness at the inframammary fold by isolating skin and subcutaneous tissue at the inframammary fold, pinching firmly, and measuring the thickness with a caliper. | Day 30, 90, 180 | 
| Bilateral analysis of male chest measurements | Measurement of suprasternal notch to nipple, inter-nipple distance, suprasternal notch to nipple plane, midclavicular point to nipple, nipple plane to umbilicus, umbilicus to pubic symphysis, coracoid process to nipple plane, nipple plane to medial epicondyle, and coracoid process to medial epicondyle. | Day 30, 90, 180 | 
| Bilateral analysis of skin excised during the procedure by Gynecomastia Grade | Measurement of the amount of skin excised (if any). | Day 30, 90, 180 | 
| Bilateral analysis of gland tissue removal methods during the procedure by Gynecomastia Grade. | Measurement of the amount of gland tissue removed (if any). | Day 30, 90, 180 | 
| The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, will complete a bilateral Physician Global Aesthetic Improvement Scale assessing overall aesthetic improvement in the treatment area | Rating scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse | Day 30, 90, 180 | 
| The subject will complete a bilateral Subject Global Aesthetic Improvement Scale assessing overall aesthetic improvement in the treatment area | Rating scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse | Day 30, 90, 180 | 
| The subject will complete a bilateral Patient Satisfaction Questionnaire | Evaluation of satisfaction for the right side and for the left side. | Day 30, 90, 180 | 
| Baseline images compared to Day 30, 90, and 180 images will be assessed for correct identification of Renuvion-treated side by blinded Independent Photographic Reviewers | Three experienced, blinded photographic reviewers will perform a qualitative analysis/review of pre-treatment and post-treatment sets of images for each subject. Images will be provided in a blinded and randomized order. Each blinded reviewer will choose which side of the chest was treated with Renuvion. Success will be correct identification of treated side of the chest by at least 2 of the 3 reviewers. | Day 30, 90, 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renuvion, Helium Plasma