Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Bilateral gynecomastia surgery with Renuvion APR System right side 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
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.
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| Active Comparator: Bilateral gynecomastia surgery with Renuvion APR System left side 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
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.
|
Outcome Measures
Primary Outcome Measures
- Analysis of bilateral occurrence of adverse events [Through Day 180]
Analysis of bilateral occurrence of adverse events
Secondary Outcome Measures
- Bilateral analysis of change to Soft-Tissue Pinch Thickness of the Upper Pole [Day 30, 90, 180]
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.
- Bilateral analysis of change to Soft-Tissue Pinch Thickness at the Inframammary Fold [Day 30, 90, 180]
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.
- Bilateral analysis of male chest measurements [Day 30, 90, 180]
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.
- Bilateral analysis of skin excised during the procedure by Gynecomastia Grade [Day 30, 90, 180]
Measurement of the amount of skin excised (if any).
- Bilateral analysis of gland tissue removal methods during the procedure by Gynecomastia Grade. [Day 30, 90, 180]
Measurement of the amount of gland tissue removed (if any).
- 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 [Day 30, 90, 180]
Rating scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
- The subject will complete a bilateral Subject Global Aesthetic Improvement Scale assessing overall aesthetic improvement in the treatment area [Day 30, 90, 180]
Rating scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
- The subject will complete a bilateral Patient Satisfaction Questionnaire [Day 30, 90, 180]
Evaluation of satisfaction for the right side and for the left side.
- 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 [Day 30, 90, 180]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male subjects, ages 18 - 75 years old.
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ASA Physical Status Classification System Class I and Class II subjects.
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Clinical diagnosis of primary or secondary Gynecomastia.
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Gynecomastia Rohrich Grade IIA or higher.
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Symmetrical gynecomastia Rohrich grades.
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Symmetrical chest measurements (no more than 3% variance between sides).
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Scheduled for Gynecomastia surgery.
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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.
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Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation.
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Absence of physical conditions unacceptable to the investigator.
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Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits.
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Willing to release rights for the use of study photos, including in publication.
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Able to read, understand, sign, and date the informed consent.
Exclusion Criteria:
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Subjects without clinical diagnosis of primary Gynecomastia and/or a clinical diagnosis of gynecomastia with secondary causes such as medications, drugs, or testicular tumors.
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Subjects presenting with ASA Physical Status Classification System Classes III or higher.
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Gynecomastia Rohrich Grade I.
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Non-symmetrical gynecomastia Rohrich grades.
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Non-symmetrical chest measurements (more than 3% variance between sides).
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Previous treatment or surgery in the breast area.
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Active systemic or local skin disease that may alter wound healing.
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Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health.
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History of autoimmune disease (excluding Hashimoto's thyroiditis).
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Known susceptibility to keloid formation or hypertrophic scarring.
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Cancerous or pre-cancerous lesions in the area to be treated.
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Possesses a surgically implanted electronic device (i.e. pacemaker).
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Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
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Use of endermology post-procedure for the duration of the study.
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Participation in any other investigational study within 30 days prior to consent and throughout study participation.
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Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | West End Plastic Surgery | Washington | District of Columbia | United States | 20037 |
Sponsors and Collaborators
- Apyx Medical
Investigators
- Principal Investigator: Paul G Ruff, MD, West End Plastic Surgery
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APX-21-02