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

Gynecomastia Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05093049
Study type Interventional
Source Apyx Medical
Contact
Status Completed
Phase N/A
Start date October 22, 2021
Completion date August 17, 2022
View Details
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