Clinical trial NCT05323630: Evaluation of the Use of the Renuvion APR System in the Labia
Official title: Evaluation of the Use of the Renuvion APR System in the Labia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labia Enlarged
Labium; Hypertrophy
Lead sponsor: Apyx Medical
Sponsor class: INDUSTRY
First posted: 2022-04-12
Enrollment: 10
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
timeFrame: Day 90, 180
measure: Analysis of adverse events through the 180-day post-treatment visit.
timeFrame: Day 180
Secondary outcomes:
measure: Analysis of morphometric labia measurements at baseline, D30, D90, and D180.
timeFrame: Day 30, 90, 180
measure: 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.
timeFrame: Day 30, 90, 180
measure: Analysis of hypertrophy of the labia minora (Hipertrofia de Ninfas13) at baseline, D30, D90, and D180
timeFrame: Day 30, 90, 180
measure: The subject will complete a Patient Satisfaction Questionnaire (PSQ) at the 180-day follow-up visits.
timeFrame: Day 180
measure: 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
timeFrame: Post-Treatment, Day 1, 14, 30, 90, 180
measure: 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
timeFrame: Day 30, 90, 180
measure: The subject will complete a bilateral GAIS19 assessing overall aesthetic improvement in the treatment area at day 30, 90, and 180 post-treatment
timeFrame: Day 30, 90, 180
measure: The subject will complete a Female Sexual Function Index (FSFI)16 at the Baseline, 90, and 180-day follow-up visits
timeFrame: Baseline, Day 90, 180
measure: The subject will complete a Genital Appearance Satisfaction (GAS)20 scale at baseline, 90, and 180-day follow-up visits
timeFrame: Baseline, Day 90, 180
measure: Analysis of days until subject was comfortable returning to sex.
timeFrame: Post-Treatment, Day 1, Day 14, 30, 90, 180
Other outcomes:
measure: Analysis of pre- and post-treatment genital (right and left labia majora and minora) vibratory perception measurements utilizing a biothesiometer. Readings may be conducted at each follow-up visit until measurements have returned to baseline.
timeFrame: Baseline, Day 30, 90, 180
Locations:
city: Washington
country: United States
facility: Allison Plastic Martinez
state: District of Columbia
Study officials:
affiliation: West End Plastic Surgery
name: Paul G Ruff, MD
role: PRINCIPAL_INVESTIGATOR
References: