Renuvion APR System for Labial Hypertrophy

Overseen By Kari A Larson, MBA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Apyx Medical

Disqualifiers: Pregnancy, Cancer, Serious mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing the Renuvion APR System, which uses energy to tighten loose skin in the labia. It targets women who have sagging skin due to various reasons and offers a less invasive option compared to traditional surgery. Renuvion, previously branded as J-Plasma, has FDA clearance and is used in procedures like liposuction.

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the study investigator for guidance based on your specific situation.

Research Team

Paul G Ruff, MD

Principal Investigator

West End Plastic Surgery

Eligibility Criteria

This trial is for women aged 35-70 with moderate to severe labial enlargement who are in good health (ASA Class I or II). Participants must agree to use birth control if applicable, not undergo other treatments in the area during the study, and allow their photos to be used. Those with mild labial protrusion, serious health issues, allergies to local anesthetics, a history of keloid scarring or electronic implants cannot join.

Inclusion Criteria

Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation

Absence of physical conditions unacceptable to the investigator

Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits

Exclusion Criteria

Possesses a surgically implanted electronic device (i.e., pacemaker)

Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years

Labial protrusion Class I (MOTAKEF scale)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

The labia procedure utilizing the Renuvion APR system is performed as a minimally invasive alternative to surgical labiaplasty

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain levels, aesthetic improvement, and satisfaction

180 days

Multiple visits at Day 1, 14, 30, 90, and 180

Treatment Details

Interventions

• Renuvion APR System

Trial Overview The Renuvion APR System is being tested as a treatment for reducing loose skin in the labia due to various causes like childbirth or aging. The study will evaluate its effectiveness and safety through follow-up visits and assessments.

Participant Groups

Group I: Procedure with the Renuvion APR System in the labia Experimental Treatment 1 Intervention

The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice.

Who Is Running the Clinical Trial?

Apyx Medical

Lead Sponsor

Trials

10

Recruited

360+