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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Labia Enlarged, Labium; Hypertrophy

Intervention / Treatment
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* Device: Renuvion APR System


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective, single-center, single arm, evaluator-blinded study of the subjects undergoing a procedure with the Renuvion APR System in the labia. Follow-up visits will occur 1D Contact, 14D, 30D, 90D, and 180D post-procedure. Images will be captured at baseline and all follow-up visits. Three experienced, independent blinded photographic reviewers will perform a qualitative analysis/review of pre-treatment and post-treatment sets of images for each subject. Images will be provided in a blinded and randomized order. Each blinded reviewer will choose which is the before image and which is the after. Success will be correct identification of before and after by at least 2 of the 3 reviewers.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Procedure with the Renuvion APR System in the labia<br>The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. | Device: Renuvion APR System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of change between baseline and follow-up images as determined by a masked, qualitative assessment of photographs at 90-days and 180-days post-treatment compared to baseline. | Correct selection of post-treatment images by independent photographic reviewers. | Day 90, 180 | 
| Analysis of adverse events through the 180-day post-treatment visit. | Analysis of adverse events | Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of morphometric labia measurements at baseline, D30, D90, and D180. | Measurement of labia, cm | Day 30, 90, 180 | 
| Analysis of labia protrusion (distance of the lateral edge of the labia minora from that of the labia majora rather than the introitus) at baseline, D30, D90, and D180. | MOTAKEF scale of labia protrusion, Class I (0 to 2cm of protrusion), Class II (2 to 4cm), Class III (>4cm). | Day 30, 90, 180 | 
| Analysis of hypertrophy of the labia minora (Hipertrofia de Ninfas13) at baseline, D30, D90, and D180 | Hipertrofia de Ninfas scale of hypertrophy; Type I (Less than 2cm), Type II (2-4cm), Type III (4-6cm), Type IV (<6cm) | Day 30, 90, 180 | 
| The subject will complete a Patient Satisfaction Questionnaire (PSQ) at the 180-day follow-up visits. | Satisfaction Questions | Day 180 | 
| During study treatment, the subject's pain levels will be monitored using the 11-point Numeric Rating Scale (NRS)21. The average pain score for the entire region treated will be recorded. Pain scores will be recorded at all follow-up visits | 11-point Scale where 0 is no pain and 10 is most pain. | Post-Treatment, Day 1, 30, 90, 180 | 
| The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, will complete a bilateral GAIS19 assessing overall aesthetic improvement in the treatment area at day 30, 90, and 180 post-treatment | Global Aesthetic Improvement Scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse | Day 30, 90, 180 | 
| The subject will complete a bilateral GAIS19 assessing overall aesthetic improvement in the treatment area at day 30, 90, and 180 post-treatment | Global Aesthetic Improvement Scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse | Day 30, 90, 180 | 
| The subject will complete a Female Sexual Function Index (FSFI)16 at the Baseline, 90, and 180-day follow-up visits | Female Sexual Function Index (FSFI)16 evaluation; 5 Answers available per question. The individual domain scores and full-scale score of the FSFI are derived by the computational formula. | Baseline, Day 90, 180 | 
| The subject will complete a Genital Appearance Satisfaction (GAS)20 scale at baseline, 90, and 180-day follow-up visits | Genital Appearance Satisfaction (GAS)20 scale; Never, Sometimes, Often, Always responses. | Baseline, Day 90, 180 |