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

NCT05093049 | Completed Results FDA Device

• 1 other identifier: APX-21-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Gynecomastia

Keywords

Renuvion; Helium Plasma

Outcome Measures

Primary Outcomes (1)

• Analysis of Bilateral Occurrence of Adverse Events

  Analysis of bilateral occurrence of adverse events by study arm.

  Through Day 180

Secondary Outcomes (9)

• Bilateral Analysis of Change to Soft-Tissue Pinch Thickness of the Upper Pole

  Day 30, 90, 180

• Bilateral Analysis of Change to Soft-Tissue Pinch Thickness at the Inframammary Fold

  Day 30, 90, 180

• Bilateral Analysis of Male Chest Measurements

  Day 30, 90, 180

• Bilateral Analysis of the Amount of Skin Excised During the Procedure by Gynecomastia Grade (Rohrich Classification)

  Procedure

• Gland Tissue Removal by Number of Participants

  Procedure

Study Arms (2)

Gynecomastia Surgery Followed by Renuvion

ACTIVE COMPARATOR

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.

Device: Renuvion APR System; Procedure: Gynecomastia Correction Surgery

Gynecomastia Surgery Only

ACTIVE COMPARATOR

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.

Procedure: Gynecomastia Correction Surgery

Interventions

Renuvion APR System DEVICE

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.

Gynecomastia Surgery Followed by Renuvion

Gynecomastia Correction Surgery PROCEDURE

Gynecomastia correction surgery as per the investigators standard treatment of care utilizing liposuction.

Gynecomastia Surgery Followed by Renuvion; Gynecomastia Surgery Only

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Apyx Medical: lead

Study Sites (1)

West End Plastic Surgery

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Gynecomastia

Condition Hierarchy (Ancestors)

Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Limitations include limited subject numbers, potential variation in subject positioning between visits which can affect measurements, and split body design which due to natural body asymmetry between sides made it challenging to interpret results of the cohorts.

Results Point of Contact

• Title: Senior Director of Clinical Affairs
• Organization: Apyx Medical

kari.larson@apyxmedical.com

801-244-0058

Study Officials

• Paul G Ruff, MD

  West End Plastic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 26, 2021
• Study Start: October 22, 2021
• Primary Completion: August 17, 2022
• Study Completion: August 17, 2022
• Last Updated: February 8, 2024
• Results First Posted: February 8, 2024

Record last verified: 2024-02

Locations

US (1)