An interventional study of Renuvion APR System in Labia Enlarged and Labium; Hypertrophy, sponsored by Apyx Medical. Completed at 1 site in United States. Open to female participants aged 35 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Apyx Medical · Not applicable, Interventional, and Treatment
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.
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.
139 studies on the registry are indexed under Hypertrophy; 22 are open to participants now.
This study's enrollment of 10 is below the median of 34 across 112 interventional studies indexed under Hypertrophy.
Browse Hypertrophy studies →Apyx Medical is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice.
Device: Renuvion APR System
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.
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.
Time frame: Day 90, Day 180
Analysis of Morphometric Labia Measurements at D180.
Analysis by anatomical measurements of the labia majora and minora 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
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
Time frame: 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
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.
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.
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
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).
Time frame: 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.
Time frame: Post-Treatment, Day 1, Day 14, Day 30, Day 90, Day 180
| Milestone | Procedure With the Renuvion APR System in the Labia (APR-15-TP) | Procedure With the Renuvion APR System in the Labia (Micro) |
|---|---|---|
| Started | 7 | 3 |
| Completed | 7 | 3 |
| Not completed | 0 | 0 |
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.
| Sets of B/A Images analyzed | Procedure with the Renuvion APR System in the labia (APR-15-TP) | Procedure with the Renuvion APR System in the labia (Micro) |
|---|---|---|
| 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. | 4 | 4 |
Analysis by anatomical measurements of the labia majora and minora at D180.
| cm | Procedure with the Renuvion APR System in the labia (APR-15-TP) | Procedure with the Renuvion APR System in the labia (Micro) |
|---|---|---|
| Sulcus Length of Labia Majora (Posterior to Anterior Margins) Day 180 | 10.0 ± 0.6 | 10.5 ± 0.7 |
| Introital Opening to Most Anterior Projecting Edge of the Labia Minora Day 180 | 1.3 ± 0.6 | 1.3 ± 0.8 |
| Posterior Border of the Sulcus to the Fornix Day 180 | 0.9 ± 0.2 | 0.9 ± 0.1 |
| Inter-Labial Sulcus Length Day 180 | 9.0 ± 1.0 | 7.6 ± 1.5 |
| Resting Projection of Labia Minora Beyond Labia Majora Day 180 | 0.7 ± 0.5 | 0.8 ± 0.5 |
| Maximum Projection of the Labia Minora Day 180 | 1.8 ± 0.8 | 1.8 ± 0.7 |
| Maximum Projection of Labia Majora Day 180 | 1.3 ± 0.3 | 0.9 ± 0.3 |
| Arch of Labia Minora Day 180 | 8.7 ± 1.8 | 9.5 ± 1.0 |
| Arch of Labia Majora Day 180 | 10.8 ± 1.5 | 10.5 ± 0.9 |
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.
| Participants | Procedure with the Renuvion APR System in the labia (APR-15-TP) | Procedure with the Renuvion APR System in the labia (Micro) |
|---|---|---|
| Baseline — Type I-A: Less than 2cm | 0 | 0 |
| Baseline — Type II-A: From 2cm to 4cm | 6 | 3 |
| Baseline — Type II-C: From 2cm to 4cm | 1 | 0 |
| Baseline — Type II-AI: From 4cm to 6 cm | 0 | 0 |
| Baseline — Type VI-A: Greater than 6 cm | 0 | 0 |
| Day 30 — Type I-A: Less than 2cm | 3 | 2 |
| Day 30 — Type II-A: From 2cm to 4cm | 4 | 1 |
| Day 30 — Type II-C: From 2cm to 4cm | 0 | 0 |
| Day 30 — Type II-AI: From 4cm to 6 cm | 0 | 0 |
| Day 30 — Type VI-A: Greater than 6 cm | 0 | 0 |
| Day 90 — Type I-A: Less than 2cm | 3 | 2 |
| Day 90 — Type II-A: From 2cm to 4cm | 4 | 1 |
| Day 90 — Type II-C: From 2cm to 4cm | 0 | 0 |
| Day 90 — Type II-AI: From 4cm to 6 cm | 0 | 0 |
| Day 90 — Type VI-A: Greater than 6 cm | 0 | 0 |
| Day 180 — Type I-A: Less than 2cm | 5 | 2 |
| Day 180 — Type II-A: From 2cm to 4cm | 2 | 1 |
| Day 180 — Type II-C: From 2cm to 4cm | 0 | 0 |
| Day 180 — Type II-AI: From 4cm to 6 cm | 0 | 0 |
| Day 180 — Type VI-A: Greater than 6 cm | 0 | 0 |
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.
| Participants | Procedure with the Renuvion APR System in the labia (APR-15-TP) | Procedure with the Renuvion APR System in the labia (Micro) |
|---|---|---|
| Baseline — Type I: Less than 2cm | 0 | 0 |
| Baseline — Type II: From 2cm to 4cm | 7 | 3 |
| Baseline — Type III: From 4cm to 6 cm | 0 | 0 |
| Baseline — Type VI: Greater than 6 cm | 0 | 0 |
| Day 30 — Type I: Less than 2cm | 3 | 2 |
| Day 30 — Type II: From 2cm to 4cm | 4 | 1 |
| Day 30 — Type III: From 4cm to 6 cm | 0 | 0 |
| Day 30 — Type VI: Greater than 6 cm | 0 | 0 |
| Day 90 — Type I: Less than 2cm | 2 | 2 |
| Day 90 — Type II: From 2cm to 4cm | 5 | 1 |
| Day 90 — Type III: From 4cm to 6 cm | 0 | 0 |
| Day 90 — Type VI: Greater than 6 cm | 0 | 0 |
| Day 180 — Type I: Less than 2cm | 5 | 2 |
| Day 180 — Type II: From 2cm to 4cm | 2 | 1 |
| Day 180 — Type III: From 4cm to 6 cm | 0 | 0 |
| Day 180 — Type VI: Greater than 6 cm | 0 | 0 |
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.
| participants | Procedure with the Renuvion APR System in the labia (APR-15-TP) | Procedure with the Renuvion APR System in the labia (Micro) |
|---|---|---|
| Do you notice improvement in how your labia look? : Yes | 7 | 3 |
| Characterize Satisfaction With Procedure - Satisfied (Very, Satisfied, or Slightly) | 6 | 3 |
| Recommend Procedure To Friends and Family Members - Yes | 6 | 3 |
| Improvement noticed - Closer together | 1 | 1 |
| Improvement noticed - Improvement in loose skin | 4 | 3 |
| Improvement noticed - Less sagging skin | 3 | 3 |
| Improvement noticed - Majora seem smaller-Right Minora seems same or only slight improvement | 1 | 1 |
| Improvement noticed - Smoother skin texture | 2 | 1 |
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.
| Score on a Scale | Procedure with the Renuvion APR System in the labia (APR-15-TP) | Procedure with the Renuvion APR System in the labia (Micro) |
|---|---|---|
| Baseline | 0.3 ± 0.8 | 0.0 ± 0.0 |
| Day 1 | 4.1 ± 2.5 | 2.3 ± 2.1 |
| Day 14 | 3.7 ± 3.4 | 4.0 ± 1.0 |
| Day 30 | 1.6 ± 1.8 | 2.0 ± 0.0 |
| Day 90 | 0.1 ± 0.4 | 0.0 ± 0.0 |
| Day 180 | 0.0 ± 0.0 | 0.0 ± 0.0 |
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
| Participants | Procedure with the Renuvion APR System in the labia (APR-15-TP) | Procedure with the Renuvion APR System in the labia (Micro) |
|---|---|---|
| Day 30 — Worse | 0 | 0 |
| Day 30 — No Change | 2 | 0 |
| Day 30 — Improved, Much Improved, Very Much Improved | 5 | 3 |
| Day 90 — Worse | 0 | 0 |
| Day 90 — No Change | 1 | 0 |
| Day 90 — Improved, Much Improved, Very Much Improved | 6 | 3 |
| Day 180 — Worse | 0 | 0 |
| Day 180 — No Change | 0 | 0 |
| Day 180 — Improved, Much Improved, Very Much Improved | 7 | 3 |
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
| Participants | Procedure with the Renuvion APR System in the labia (APR-15-TP) | Procedure with the Renuvion APR System in the labia (Micro) |
|---|---|---|
| Day 30 — Worse | 0 | 0 |
| Day 30 — No Change | 2 | 1 |
| Day 30 — Improved, Much Improved, Very Much Improved | 5 | 2 |
| Day 90 — Worse | 0 | 0 |
| Day 90 — No Change | 0 | 1 |
| Day 90 — Improved, Much Improved, Very Much Improved | 7 | 2 |
| Day 180 — Worse | 0 | 0 |
| Day 180 — No Change | 1 | 0 |
| Day 180 — Improved, Much Improved, Very Much Improved | 6 | 3 |
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.
| Score on FSFI Scale (Range 2 - 36) | Procedure with the Renuvion APR System in the labia (APR-15-TP) | Procedure with the Renuvion APR System in the labia (Micro) |
|---|---|---|
| FSFI Baseline | 24.45 ± 1.1 | 25.17 ± 0.5 |
| FSFI Day 90 | 24.45 ± 1.1 | 27.89 ± 1.3 |
| FSFI Day 180 | 29.49 ± 0.8 | 26.51 ± 1.6 |
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).
| Score on GAS Scale (0 -30 Range) | Procedure with the Renuvion APR System in the labia (APR-15-TP) | Procedure with the Renuvion APR System in the labia (Micro) |
|---|---|---|
| Genital Appearance Satisfaction Baseline | 18.57 ± 0.6 | 22.33 ± 0.5 |
| Genital Appearance Satisfaction Day 90 | 9.14 ± 0.5 | 12.33 ± 0.4 |
| Genital Appearance Satisfaction Day 180 | 9.86 ± 0.6 | 10.67 ± 0.5 |
Subjects report the number of days until they feel comfortable returning to sex.
| Days | Procedure with the Renuvion APR System in the labia (APR-15-TP) | Procedure with the Renuvion APR System in the labia (Micro) |
|---|---|---|
| Analysis of Days Until Subject Was Comfortable Returning to Sex. | 35.7 ± 26 | 21.7 ± 8.02 |
Collected over 180 Days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Procedure With the Renuvion APR System in the Labia (APR-15-TP) | 0/7 (0%) | 0/7 (0%) | 7/7 (100%) |
| Procedure With the Renuvion APR System in the Labia (Micro) | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Event | Procedure With the Renuvion APR System in the Labia (APR-15-TP) | Procedure With the Renuvion APR System in the Labia (Micro) |
|---|---|---|
| Crepitus (ETE)Skin and subcutaneous tissue disorders | 7/7 | 3/3 |
| Edema (ETE)Surgical and medical procedures | 7/7 | 3/3 |
| Hypoesthesia/Numbness (ETE)Skin and subcutaneous tissue disorders | 7/7 | 3/3 |
| Pain/TendernessSkin and subcutaneous tissue disorders | 6/7 | 2/3 |
| WoundSurgical and medical procedures | 3/7 | 0/3 |
| Bruise (ETE)Skin and subcutaneous tissue disorders | 2/7 | 1/3 |
| Pruritus/Itching (ETE)Skin and subcutaneous tissue disorders | 1/7 | 0/3 |
| HematomaSkin and subcutaneous tissue disorders | 1/7 | 0/3 |
| Age, Categorical(Participants) | Procedure With the Renuvion APR System in the Labia | Procedure With the Renuvion Micro System in the Labia | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 3 | 10 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(Years) | Procedure With the Renuvion APR System in the Labia | Procedure With the Renuvion Micro System in the Labia | Total |
|---|---|---|---|
| Median | 41 ± 4 | 41 ± 8.5 | 41 ± 5.1 |
| Sex: Female, Male(Participants) | Procedure With the Renuvion APR System in the Labia | Procedure With the Renuvion Micro System in the Labia | Total |
|---|---|---|---|
| Female | 7 | 3 | 10 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Procedure With the Renuvion APR System in the Labia | Procedure With the Renuvion Micro System in the Labia | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 6 | 3 | 9 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Procedure With the Renuvion APR System in the Labia | Procedure With the Renuvion Micro System in the Labia | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 3 | 1 | 4 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Procedure With the Renuvion APR System in the Labia | Procedure With the Renuvion Micro System in the Labia | Total |
|---|---|---|---|
| United States | 7 | 3 | 10 |
| BMI(kg/m2) | Procedure With the Renuvion APR System in the Labia | Procedure With the Renuvion Micro System in the Labia | Total |
|---|---|---|---|
| Mean | 25.246 (19.63 to 31.16) | 26.773 (25.13 to 27.72) | 25.704 (19.63 to 31.16) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2023 to primary completion in Apr 2024, 12 months.
Results were first posted in Dec 2025, 1 year 8 months after primary completion.
Of 78 interventional studies with no phase under Hypertrophy, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 22. This study's 12 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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