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 range
18 Years – 75 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Analysis of Bilateral Occurrence of Adverse Events
. Non-symmetrical chest measurements (more than 3% variance between sides).
. 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.