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

NCT05323630 | Completed Results FDA Device

• 1 other identifier: APX-22-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Labia Enlarged; Labium; Hypertrophy

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Day 90, Day 180

Secondary Outcomes (10)

• 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

Study Arms (1)

Procedure with the Renuvion APR System in the labia

OTHER

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

Device: Renuvion APR System

Interventions

Renuvion APR System 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.

Procedure with the Renuvion APR System in the labia

Eligibility Criteria

• Age: 35 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Apyx Medical: lead

Study Sites (1)

Allison Plastic Martinez

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Hypertrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Paul G. Ruff, MD
• Organization: West End Plastic Surgery

drruff@westendplasticsurgery.com

202-785-4187

Study Officials

• Paul G Ruff, MD

  West End Plastic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 12, 2022
• Study Start: April 19, 2023
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: December 23, 2025
• Results First Posted: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)