At a glance
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A Pilot Study of the Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery
In Brief
A clinical study evaluating Renuvion APR System and Gynecomastia Correction Surgery for Gynecomastia. Completed, enrolled 10 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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 correction surgery as per the investigators standard treatment of care utilizing liposuction.