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Plasma Device

Renuvion APR System for Labial Hypertrophy

N/A

Waitlist Available

Led By Paul G Ruff, MD

Research Sponsored by Apyx Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female subjects, ages 35 - 70 years old

ASA Physical Status Classification System Class I and Class II subjects

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-treatment, day 1, 30, 90, 180

Awards & highlights

Study Summary

This trial is a surgery to reduce excess skin in the external genital area, caused by childbirth, trauma, aging, genetics, or congenital disease.

Who is the study for?

This trial is for women aged 35-70 with moderate to severe labial enlargement who are in good health (ASA Class I or II). Participants must agree to use birth control if applicable, not undergo other treatments in the area during the study, and allow their photos to be used. Those with mild labial protrusion, serious health issues, allergies to local anesthetics, a history of keloid scarring or electronic implants cannot join.Check my eligibility

What is being tested?

The Renuvion APR System is being tested as a treatment for reducing loose skin in the labia due to various causes like childbirth or aging. The study will evaluate its effectiveness and safety through follow-up visits and assessments.See study design

What are the potential side effects?

While specific side effects are not listed here, potential risks may include reactions similar to those from surgical procedures such as pain at the site of treatment, swelling, bruising, infection risk and possible scarring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged between 35 and 70.

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I am in good or mild systemic disease health according to the ASA classification.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-treatment, day 1, 30, 90, 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-treatment, day 1, 30, 90, 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-treatment, day 1, 30, 90, 180 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Analysis of adverse events through the 180-day post-treatment visit.

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.

Secondary outcome measures

Analysis of hypertrophy of the labia minora (Hipertrofia de Ninfas13) at baseline, D30, D90, and D180

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.

Analysis of morphometric labia measurements at baseline, D30, D90, and D180.

+6 more

Other outcome measures

• Analysis of pre- and post-treatment genital (right and left labia majora and minora) vibratory perception measurements utilizing a biothesiometer. Readings may be conducted at each follow-up visit until measurements have returned to baseline.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Procedure with the Renuvion APR System in the labiaExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Renuvion APR System

2021

N/A

~30

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Apyx MedicalLead Sponsor

9 Previous Clinical Trials

348 Total Patients Enrolled

Paul G Ruff, MDPrincipal InvestigatorWest End Plastic Surgery

1 Previous Clinical Trials

10 Total Patients Enrolled

Media Library

Renuvion APR System (Plasma Device) Clinical Trial Eligibility Overview. Trial Name: NCT05323630 — N/A

Labial Hypertrophy Research Study Groups: Procedure with the Renuvion APR System in the labia

Labial Hypertrophy Clinical Trial 2023: Renuvion APR System Highlights & Side Effects. Trial Name: NCT05323630 — N/A

Renuvion APR System (Plasma Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05323630 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the criteria for participation in this clinical experiment?

"To be considered for this medical trial, potential participants must have labial hypertrophy and range from 35 to 70 years old. Approximately 15 successful candidates will be enrolled in the study."

Answered by AI

Are there any available vacancies for those who wish to participate in this research?

"Affirmative. Clinicaltrials.gov shows that this medical trial is actively recruiting, as the posting date was April 19th 2023 and it has been updated on May 2nd of the same year. 15 participants will be chosen from 1 clinical site for admission into this study."

Answered by AI

Does this research encompass adults aged 18 and above?

"Patients aged 35 to 70 years are invited to partake in this research."

Answered by AI

How many participants has this research project been able to enroll?

"Affirmative. The information available on clinicaltrials.gov implies that recruitment for this experiment is underway; the trial was initially posted on April 19th 2023 and recently modified on May 2nd 2023. There are 15 spots open across a single medical centre."

Answered by AI

What are the chief goals of this experiment?

"The primary endpoint of this clinical trial, which will be measured at approximately 90 and 180 days post-treatment is the analysis of adverse events. Secondary objectives include subject's completion of a Genital Appearance Satisfaction (GAS)20 scale over baseline, 90 day, and 180 day follow up visits; Global Aesthetic Improvement Scale assessment by the principal investigator or their delegate to measure overall aesthetic improvement in treatment area on Day 30, Day 90, and Day 180; as well as an evaluation using MOTAKEF labia protrusion scale from 0 cm to 4+ cm across four classes on Baseline timepoint, D30, D90"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Evaluation of the Use of the Renuvion APR System in the Labia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05323630.

All > Hypertrophy