Evaluation of the Use of the Renuvion APR System in the Labia

NCT ID: NCT05323630

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-19
• Study Completion Date: 2024-04-23

Brief Summary

Labiaplasty is a procedure aimed at reducing lax or loose skin in the labia majora and/or minora due to childbirth, trauma, aging, genetics, or congenital disease.

Detailed Description

While traditional surgical procedures have been associated with complications such as dehiscence, hematoma, flap necrosis, narrowed introitus, and pain and asymmetry, correction with RF energy has shown minimal complication rates with high patient satisfaction. This study aims to evaluate the use of the Renuvion APR System for use as a minimally invasive alternative to surgical labiaplasty.

Conditions

Labia Enlarged; Labium; Hypertrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Procedure with the Renuvion APR System in the labia

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

Group Type: OTHER

Renuvion APR System

Intervention Type: DEVICE

The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.

Interventions

Renuvion APR System

The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Female subjects, ages 35 - 70 years old.
• ASA Physical Status Classification System Class I and Class II subjects.
• Labial protrusion Class II and Class III (MOTAKEF scale)12.
• Females who do not desire traditional invasive surgery.
• 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.
• Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.
• Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits.
• Willing to release rights for the use of study photos, including in publication.
• Able to read, understand, sign, and date the informed consent.

Exclusion Criteria

• Labial protrusion Class I (MOTAKEF scale).
• Subjects presenting with ASA Physical Status Classification System Classes III or higher.
• Pregnant, lactating, or plans to become pregnant during study participation.
• Known hypersensitivity or allergy to tumescent anesthetic (lidocaine/ epinephrine).
• Previous treatment in the study treatment 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.
• Known susceptibility to keloid formation or hypertrophic scarring.
• Cancerous or pre-cancerous lesions in the area to be treated.
• 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.
• Participation in any other investigational study within 30 days prior to consent and throughout study participation.
• Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Apyx Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul G Ruff, MD

Role: PRINCIPAL_INVESTIGATOR

West End Plastic Surgery

Locations

Allison Plastic Martinez

Washington D.C., District of Columbia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

APX-22-02

Identifier Type: -

Identifier Source: org_study_id