Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery (NCT05093049) | Clinical Trial Compass
CompletedNot Applicable
Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery
United States10 participantsStarted 2021-10-22
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexMALE
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Inclusion criteria
✓. Male subjects, ages 18 - 75 years old.
✓. ASA Physical Status Classification System Class I and Class II subjects.
✓. Clinical diagnosis of primary or secondary Gynecomastia.
✓. Gynecomastia Rohrich Grade IIA or higher.
✓. Symmetrical gynecomastia Rohrich grades.
✓. Symmetrical chest measurements (no more than 3% variance between sides).
✓. Scheduled for Gynecomastia surgery.
✓. Willing to have Renuvion APR System as an adjunct procedure on one side understanding that an optional balancing procedure may be provided post-study exit.
Exclusion criteria
✕. Subjects without clinical diagnosis of primary Gynecomastia and/or a clinical diagnosis of gynecomastia with secondary causes such as medications, drugs, or testicular tumors.
✕. Subjects presenting with ASA Physical Status Classification System Classes III or higher.
✕. Gynecomastia Rohrich Grade I.
✕. Non-symmetrical gynecomastia Rohrich grades.
✕. Non-symmetrical chest measurements (more than 3% variance between sides).
What they're measuring
1
Analysis of Bilateral Occurrence of Adverse Events
. Previous treatment or surgery in the breast area.
✕. Active systemic or local skin disease that may alter wound healing.
✕. Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health.