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Clinical Trials/NCT05323630
NCT05323630CompletedNot Applicable

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

Apyx Medical2 sites in 1 country10 target enrollmentStarted: April 19, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
2
Primary Endpoint
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.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
35 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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)
  • •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.

Outcomes

Primary Outcomes

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.

Time Frame: Day 90, Day 180

Three experienced, blinded photographic reviewers performed a qualitative analysis/review of pre-treatment and post-treatment sets of images at 90-days and 180-days post-treatment compared to baseline for each subject. Images were provided in a blinded and randomized order. Each blinded reviewer choose which set of images were the post-treated Renuvion images of the labia. Change was assessed as success with success being the correct identification of treated labia images by at least 2 of the 3 reviewers.

Secondary Outcomes

  • Analysis of Morphometric Labia Measurements at D180.(Day 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.(Day 30, Day 90, Day 180)
  • Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180(Day 30, Day 90, Day 180)
  • The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit.(Day 180)
  • During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS).(Post-Treatment, Day 1, Day 14, Day 30, Day 90, Day 180)
  • The Principal Investigator, Sub-investigator or Qualified Clinician Delegated by the Principal Investigator, Will Complete a Bilateral Global Aesthetic Improvement Scale (GAIS) Assessing Overall Aesthetic Improvement in the Treatment Area.(Day 30, Day 90, Day 180)
  • The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area.(Day 30, Day 90, Day 180)
  • The Subject Will Complete a Female Sexual Function Index (FSFI) to Assess the Sexual Function to Evaluate the Impact of Treatment to the Labia.(Baseline, Day 90, Day 180)
  • The Subject Will Complete a Genital Appearance Satisfaction (GAS) at Baseline, 90, and 180-day Follow-up Visits(Baseline, Day 90, Day 180)
  • Analysis of Days Until Subject Was Comfortable Returning to Sex.(Post-Treatment, Day 1, Day 14, Day 30, Day 90, Day 180)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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