Labia EnlargedNCT05323630
Evaluation of the Use of the Renuvion APR System in the Labia
A study testing Renuvion APR System in people with Labia Enlarged and Labium; Hypertrophy, run by Apyx Medical at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labia Enlarged, Labium; Hypertrophy
- What is being tested?
- Renuvion APR System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2023to 23 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Allison Plastic Martinez
Washington D.C., District of Columbia, 20037
About this study
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.
Read the 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.
- Conditions
- Labia Enlarged, Labium; Hypertrophy
- Being tested
- Renuvion APR System
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renuvion APR SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Renuvion APR System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 90, Day 180
Secondary outcomes (10)
Analysis of Morphometric Labia Measurements at D180.
Analysis by anatomical measurements of the labia majora and minora at D180.
Measured: 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.
MOTAKEF scale of labia protrusion, Type I-A: Less than 2cm, Type II-A: From 2cm to 4cm, Type II-C: From 2cm to 4cm, Type II-AI: From 4cm to 6 cm, Type VI-A: Greater than 6 cm. The greater the class the greater area of protrusion of labia minora past the labia majora. An "A" is added for asymmetry and a "C" for involvement of the clitoral hood.
Measured: Day 30, Day 90, Day 180
Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180
Hipertrofia de Ninfas scale of hypertrophy; Type I (Less than 2cm), Type II (2-4cm), Type III (4-6cm), Type IV (<6cm). The lower the type the better the outcome.
Measured: Day 30, Day 90, Day 180
The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit.
The subjects completed a Patient Satisfaction Questionnaire (PSQ) at the Day 180 follow-up visit. The subject completed this assessment while referring to baseline photos, current photos, and a hand mirror.
Measured: Day 180
During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS).
During study treatment, the subject's pain levels were monitored using the 11-point Numeric Rating Scale (NRS). The average pain score for the entire region treated was recorded. Pain scores will be recorded at all follow-up visits. NRS 11-point Scale where 0 is no pain and 10 is most pain.
Measured: 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.
The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, completed a bilateral GAIS assessing overall aesthetic improvement in the treatment area at Day 30, Day 90, and Day 180 post-treatment.
Global Aesthetic Improvement Scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Measured: Day 30, Day 90, Day 180
The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area.
The subject completed a GAIS assessing overall aesthetic improvement in the treatment area at Day 30, Day 90, and Day 180 post-treatment.
Global Aesthetic Improvement Scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Measured: 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.
Female Sexual Function Index (FSFI) evaluation which measures desire, arousal, lubrication, orgasm, satisfaction, and pain, was administered at baseline, Day 90, and Day 180; 5 Answers available per question. The individual domain scores and full-scale score of the FSFI are derived by the computational formula. Response options for questions were: 0=no sexual activity, 5=almost always or always, 4=most times (more than half the time), 3=sometimes (about half the time), 2=a few times (less than half the time), 1=almost never or never. Individual domain scores are obtained by adding the scores of the individual items that comprise the domain and multiplying the sum by the specified domain factor. The full-scale score is obtained by adding the six domain scores with potential ranges from 2 to 36.
Measured: Baseline, Day 90, Day 180
The Subject Will Complete a Genital Appearance Satisfaction (GAS) at Baseline, 90, and 180-day Follow-up Visits
The Genital Appearance Satisfaction (GAS) scale was used to assess the satisfaction of subjects with their genital appearance following treatment to the labia at baseline, Day 90, and Day 180. The higher the GAS score reveals the greater dissatisfaction. Response options for each section of questions were Never (score 3), Sometimes (score 2), Often (score 1), Always (score 0). Question response values were added together for a final score for each participant. The best response would be 0 (no dissatisfaction). The worse response would be 30 (dissatisfaction across all questions).
Measured: Baseline, Day 90, Day 180
Analysis of Days Until Subject Was Comfortable Returning to Sex.
Subjects report the number of days until they feel comfortable returning to sex.
Measured: Post-Treatment, Day 1, Day 14, Day 30, Day 90, Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start19 Apr 2023
- Primary completion23 Apr 2024
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Labia EnlargedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apyx Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul G Ruff, MD, Principal investigator, West End Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323630
- Sponsor's protocol ID
- APX-22-02
- Status last verified
- Dec 2025
- First submitted
- 5 Apr 2022
- Last updated
- 23 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of the Renuvion APR System in the Labia
- ClinicalTrials.gov ID
- NCT05323630
- Acronym / sponsor ID
- APX-22-02
- Conditions
- Labia Enlarged, Labium; Hypertrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Apyx MedicalIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Posted 23 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Procedure with the Renuvion APR System in the labia | Other | Device: Renuvion APR SystemThe labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renuvion APR SystemThe 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. | Device | Procedure with the Renuvion APR System in the labia |
Primary outcome
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.
10 secondary outcomes
Analysis of Morphometric Labia Measurements at D180.
Time frame: 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.
Time frame: Day 30, Day 90, Day 180
Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180
Time frame: Day 30, Day 90, Day 180
The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit.
Time frame: Day 180
During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS).
Time frame: 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.
Time frame: Day 30, Day 90, Day 180
The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area.
Time frame: 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.
Time frame: Baseline, Day 90, Day 180
The Subject Will Complete a Genital Appearance Satisfaction (GAS) at Baseline, 90, and 180-day Follow-up Visits
Time frame: Baseline, Day 90, Day 180
Analysis of Days Until Subject Was Comfortable Returning to Sex.
Time frame: Post-Treatment, Day 1, Day 14, Day 30, Day 90, Day 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul G Ruff, MD principal investigator
West End Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renuvion APR System in people with Labia Enlarged and Labium; Hypertrophy, run by Apyx Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Day 90, Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.