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Gynecomastia Surgery Followed by Renuvion for Gynecomastia

N/A
Waitlist Available
Led By Paul G Ruff, MD
Research Sponsored by Apyx Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 30, 90, 180
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of using the Renuvion System during surgery to treat gynecomastia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 30, 90, 180
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30, 90, 180 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Analysis of Bilateral Occurrence of Adverse Events
Secondary outcome measures
Bilateral Analysis of Change to Soft-Tissue Pinch Thickness at the Inframammary Fold
Bilateral Analysis of Change to Soft-Tissue Pinch Thickness of the Upper Pole
Bilateral Analysis of Male Chest Measurements
+6 more

Trial Design

2Treatment groups
Active Control
Group I: Gynecomastia Surgery Followed by RenuvionActive Control2 Interventions
Patients receiving gynecomastia correction surgery followed by Renuvion treatment were randomly assigned to the left or the right side of the chest in a split-body randomized design. The gynecomastia surgery and Renuvion APR System use will be as per investigator's standard clinical practice.
Group II: Gynecomastia Surgery OnlyActive Control1 Intervention
Patients receiving gynecomastia correction surgery followed by Renuvion treatment were randomly assigned to the left or the right side of the chest in a split-body randomized design. The gynecomastia surgery will be as per investigator's standard clinical practice.

Who is running the clinical trial?

Apyx MedicalLead Sponsor
9 Previous Clinical Trials
348 Total Patients Enrolled
Paul G Ruff, MDPrincipal InvestigatorWest End Plastic Surgery
1 Previous Clinical Trials
10 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery
2021. "Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05093049.
~3 spots leftby Apr 2025
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