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

Apyx Medical

Status: Completed

Conditions: Gynecomastia

Treatments: Procedure: Gynecomastia Correction Surgery; Device: Renuvion APR System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05093049

APX-21-02

Details and patient eligibility

About

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 was conducted at a single investigational center in the United States.

Full 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 was conducted at a single investigational center in the United States.

At baseline, the grade of gynecomastia was 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 were as per investigator's standard clinical practice. During the procedure, fat transfer and treatment of the lateral chest and/or axilla was not allowed. The Renuvion APR System was used on one side only. The Renuvion treated side was randomized and the patient was blinded as to which side of the chest received Renuvion. Procedure data and adverse events were captured. Endermology was not allowed post-procedure. Post-procedure compression was used for 2-3 weeks with a standard compression vest for all subjects.

Follow-up images, grade of gynecomastia, and male chest measurements were taken at D30/D90/D180.

All images were assessed for correct identification of Renuvion-treated side by blinded Independent Photographic Reviewers (IPR) following the D180 visit.

Following study participation, the subject was offered an optional balancing treatment to the side not previously treated with Renuvion.

Enrollment: 10 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male subjects, ages 18 - 75 years old.
2. ASA Physical Status Classification System Class I and Class II subjects.
3. Clinical diagnosis of primary or secondary Gynecomastia.
4. Gynecomastia Rohrich Grade IIA or higher.
5. Symmetrical gynecomastia Rohrich grades.
6. Symmetrical chest measurements (no more than 3% variance between sides).
7. Scheduled for Gynecomastia surgery.
8. 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.
9. Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation.
10. Absence of physical conditions unacceptable to the investigator.
11. Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits.
12. Willing to release rights for the use of study photos, including in publication.
13. Able to read, understand, sign, and date the informed consent.

Exclusion criteria

1. Subjects without clinical diagnosis of primary Gynecomastia and/or a clinical diagnosis of gynecomastia with secondary causes such as medications, drugs, or testicular tumors.
2. Subjects presenting with ASA Physical Status Classification System Classes III or higher.
3. Gynecomastia Rohrich Grade I.
4. Non-symmetrical gynecomastia Rohrich grades.
5. Non-symmetrical chest measurements (more than 3% variance between sides).
6. Previous treatment or surgery in the breast area.
7. Active systemic or local skin disease that may alter wound healing.
8. Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health.
9. History of autoimmune disease (excluding Hashimoto's thyroiditis).
10. Known susceptibility to keloid formation or hypertrophic scarring.
11. Cancerous or pre-cancerous lesions in the area to be treated.
12. Possesses a surgically implanted electronic device (i.e. pacemaker).
13. Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
14. Use of endermology post-procedure for the duration of the study.
15. Participation in any other investigational study within 30 days prior to consent and throughout study participation.
16. Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 2 patient groups

Gynecomastia Surgery Followed by Renuvion

Active Comparator group

Description:

Patients receiving gynecomastia correction surgery followed by Renuvion treatment were randomly assigned to the left or the right side of the chest in a split-body randomized design. The gynecomastia surgery and Renuvion APR System use will be as per investigator's standard clinical practice.

Treatment:

Procedure: Gynecomastia Correction Surgery

Device: Renuvion APR System

Gynecomastia Surgery Only

Active Comparator group

Description:

Patients receiving gynecomastia correction surgery followed by Renuvion treatment were randomly assigned to the left or the right side of the chest in a split-body randomized design. The gynecomastia surgery will be as per investigator's standard clinical practice.

Treatment:

Procedure: Gynecomastia Correction Surgery