NCT05093049

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Apyx Medical · Industry
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

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 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.

Conditions

• Gynecomastia

Interventions

Type	Name	Description
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.
PROCEDURE	Gynecomastia Correction Surgery	Gynecomastia correction surgery as per the investigators standard treatment of care utilizing liposuction.

Timeline

• Start date: 2021-10-22
• Primary completion: 2022-08-17
• Completion: 2022-08-17
• First posted: 2021-10-26
• Last updated: 2024-02-08
• Results posted: 2024-02-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study