Evaluation of the Use of the Renuvion APR System in the Labia
- Conditions
- Labia EnlargedLabium; Hypertrophy
- Interventions
- Device: Renuvion APR System
- Registration Number
- NCT05323630
- Lead Sponsor
- Apyx Medical
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 10
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Procedure with the Renuvion APR System in the labia Renuvion APR System The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice.
- Primary Outcome Measures
Name Time Method 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. Day 90, 180 Correct selection of post-treatment images by independent photographic reviewers.
Analysis of adverse events through the 180-day post-treatment visit. Day 180 Analysis of adverse events
- Secondary Outcome Measures
Name Time Method 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. Day 30, 90, 180 MOTAKEF scale of labia protrusion, Class I (0 to 2cm of protrusion), Class II (2 to 4cm), Class III (\>4cm).
The subject will complete a bilateral GAIS19 assessing overall aesthetic improvement in the treatment area at day 30, 90, and 180 post-treatment Day 30, 90, 180 Global Aesthetic Improvement Scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
The subject will complete a Female Sexual Function Index (FSFI)16 at the Baseline, 90, and 180-day follow-up visits Baseline, Day 90, 180 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.
The subject will complete a Genital Appearance Satisfaction (GAS)20 scale at baseline, 90, and 180-day follow-up visits Baseline, Day 90, 180 Genital Appearance Satisfaction (GAS)20 scale; Never, Sometimes, Often, Always responses.
Analysis of morphometric labia measurements at baseline, D30, D90, and D180. Day 30, 90, 180 Measurement of labia, cm
Analysis of hypertrophy of the labia minora (Hipertrofia de Ninfas13) at baseline, D30, D90, and D180 Day 30, 90, 180 Hipertrofia de Ninfas scale of hypertrophy; Type I (Less than 2cm), Type II (2-4cm), Type III (4-6cm), Type IV (\<6cm)
The subject will complete a Patient Satisfaction Questionnaire (PSQ) at the 180-day follow-up visits. Day 180 Satisfaction Questions
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 Post-Treatment, Day 1, 14, 30, 90, 180 11-point Scale where 0 is no pain and 10 is most pain.
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 Day 30, 90, 180 Global Aesthetic Improvement Scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Analysis of days until subject was comfortable returning to sex. Post-Treatment, Day 1, Day 14, 30, 90, 180 Subjects report the number of days until they feel comfortable returning to sex.
Trial Locations
- Locations (1)
Allison Plastic Martinez
🇺🇸Washington, District of Columbia, United States