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 will be conducted at up to 3 investigational centers in the United States.~At baseline, the grade of gynecomastia will be 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 will be as per investigator's standard clinical practice. During the procedure, fat transfer and treatment of the lateral chest and/or axilla is not allowed. The Renuvion APR System will be used on one side only. The treated side will be randomized and the patient will be blinded as to which side of the chest received Renuvion. Procedure data and adverse events will be captured. Endermology is not allowed post-procedure. Post-procedure compression will be used for 2-3 weeks with a standard compression vest for all subjects.~Follow-up images, grade of gynecomastia, and male chest measurements will be taken at D30/D90/D180.~All images will be assessed for correct identification of Renuvion-treated side by blinded Independent Photographic Reviewers (IPR) following the D180 visit.~Following study participation, the subject will be offered an optional balancing treatment to the side not previously treated with Renuvion.
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 will be conducted at up to 3 investigational centers in the United States.