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

Completed · Not applicable

Conditions studied: Labia Enlarged, Labium; Hypertrophy

In brief

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.

Key facts

Study ID

NCT05323630

Run by

Apyx Medical

People needed

10

Starts

2023-04-19

Expected to finish

2024-04-23

Last updated by the study team

2025-12-23

Who can join

Age: 35 and older, up to 70. Sex: female. Healthy volunteers: accepted.

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.

Where it is running

• Allison Plastic Martinez — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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