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

NACompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

October 22, 2021

Primary Completion Date

August 17, 2022

Study Completion Date

August 17, 2022

Conditions
Gynecomastia
Interventions
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.

Trial Locations (1)

20037

West End Plastic Surgery, Washington D.C.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Apyx Medical

INDUSTRY

NCT05093049 - Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery | Biotech Hunter | Biotech Hunter