Renuvion APR System for Labial Hypertrophy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the Renuvion APR System for women with loose or protruding labial skin due to factors like childbirth or aging. The goal is to determine if this procedure can effectively tighten the skin without traditional surgery. Women with noticeable labial protrusion seeking a non-invasive option might be suitable candidates. Participants should be willing to attend follow-up visits and permit the use of study photos. As an unphased trial, this study offers a unique opportunity to explore a non-invasive treatment and contribute to advancing medical understanding.
Do I need to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the study investigator for guidance based on your specific situation.
What prior data suggests that the Renuvion APR System is safe for labial hypertrophy?
Research has shown that the Renuvion APR System is generally well-tolerated. In one study, no serious adverse reactions were linked to the procedure or the device itself. Most participants reported only mild to moderate pain after the procedure, lasting up to seven days. This suggests that the treatment may be safe to use.
However, the FDA has not yet confirmed the Renuvion device's safety or effectiveness for improving skin in cosmetic procedures. The device is approved for general surgical use, such as cutting and stopping bleeding in soft tissue. While some evidence supports its safety, it is still under study for cosmetic applications like this one.12345Why are researchers excited about this trial?
Unlike traditional surgical options for labial hypertrophy, the Renuvion APR System uses a unique approach by combining helium plasma and radiofrequency energy to precisely target and refine tissues. This method allows for greater control and precision, potentially leading to less tissue damage and a faster recovery time compared to conventional surgery. Researchers are excited about this treatment because it offers a minimally invasive alternative that could improve cosmetic results and patient satisfaction.
What evidence suggests that the Renuvion APR System is effective for labial hypertrophy?
Research has shown that the Renuvion APR System effectively tightens loose skin in the labia. One study found a reduction in skin surface area by 22% after one month and 17% after three months. Another study reported an average improvement in skin tightness of 26%. Patients experienced less pain over time, with no pain by day 90 or 180, depending on the tool used. Overall, studies found that patients were more satisfied with their results and did not experience additional complications.16789
Who Is on the Research Team?
Paul G Ruff, MD
Principal Investigator
West End Plastic Surgery
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
The labia procedure utilizing the Renuvion APR system is performed as a minimally invasive alternative to surgical labiaplasty
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pain levels, aesthetic improvement, and satisfaction
What Are the Treatments Tested in This Trial?
Interventions
- Renuvion APR System
Trial Overview
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.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Apyx Medical
Lead Sponsor
Citations
Evaluation of the Use of the Renuvion System in the Labia ...
Pain levels decreased over time, with no pain reported by day 180 in the APR handpiece group and by day 90 for the Micro handpiece. Global ...
Safety and Efficacy of Renuvion Helium Plasma to Improve ...
One study showed an average skin surface area reduction of 22% and 17% at 1- and 3-month follow-up visits, respectively, and an average of 26% skin tightening ...
3.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT05323630/evaluation-of-the-use-of-the-renuvion-apr-system-in-the-labiaEvaluation of the Use of the Renuvion APR System in ...
This study aims to evaluate the use of the Renuvion APR System for use as a minimally invasive alternative to surgical labiaplasty. Connect with ...
4.
nasdaq.com
nasdaq.com/articles/apyx-medical-announces-positive-outcomes-two-clinical-studies-evaluating-renuvionr-bodyApyx Medical Announces Positive Outcomes from Two ...
The studies reported improved skin laxity and higher satisfaction in patients treated with Renuvion, without increased complications. How many ...
5.
journals.lww.com
journals.lww.com/annalsplasticsurgery/fulltext/9900/a_systematic_review_of_helium_plasma.903.aspxA Systematic Review of Helium Plasma Radiofrequency...
Evaluation of the use of the Renuvion APR system in the labia. Available at: https://clinicaltrials.gov/study/NCT05323630?intr=Renuvion&rank ...
Evaluation of the Use of the Renuvion APR System in ...
Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...
Use of Renuvion/J-Plasma Device for Certain Aesthetic ...
The use of the device had not been determined to be safe or effective for any aesthetic skin procedures (procedures intended to improve the ...
8.
researchgate.net
researchgate.net/publication/369091195_Safety_and_Efficacy_of_Renuvion_Helium_Plasma_to_Improve_the_Appearance_of_Loose_Skin_in_the_Neck_and_Submental_Region(PDF) Safety and Efficacy of Renuvion Helium Plasma to ...
The primary safety endpoint was met; 96.9% of subjects experienced no pain to moderate pain to Day 7. There were no serious adverse events ...
9.
americanboardcosmeticsurgery.org
americanboardcosmeticsurgery.org/news/fda-releases-warning-about-renuvion/FDA Releases Warning About Renuvion - ABCS
The FDA safety communication reiterates that Renuvion is FDA-cleared for “general use of cutting, coagulation, and ablation of soft tissue” during surgery.
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