Renuvion APR Device to Improve the Appearance of Lax Tissue in the Neck and Submental Region

Study Overview
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Brief Summary
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This is a prospective, multi-center, multi-phase, evaluator-blinded study of subjects undergoing a procedure with the Renuvion APR Device to improve the appearance of lax tissue in the neck and submental region.

Detailed Description
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This is a prospective, multi-center, multi-phase, evaluator-blinded study of subjects undergoing a procedure to improve the appearance of lax tissue in the neck and submental region. All study subjects will be treated with the Renuvion APR Device. Phase I (n=17) of this study will be conducted primarily to provide safety data, however, effectiveness data will also be collected at the above stated timepoints through 6 months post-procedure. Phase II (n=65) of this study is the expansion of the study to a pivotal study.

Official Title
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A Prospective, Multi-Center, Evaluator-Blinded Study Evaluating the Safety and Effectiveness of the Renuvion APR Device to Improve the Appearance of Lax Tissue in the Neck and Submental Region

Conditions
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Lax Skin

Intervention / Treatment
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* Device: Renuvion APR Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects 35-65 years of age (inclusive). Healthy as determined by the investigator examining the subject. Seeking improvement of the appearance of lax tissue in the neck and submental region. 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 obtaining study-required images/photos and assessments, and returning for follow-up visits. Willing to release rights for the use of study photos, including in potential publication. Understands and accepts the obligation not to have significant weight loss or weight gain (≥8 pounds) post the treatment, and for the duration of participation in the study. Willing to abstain from the use of blood thinners (including, but not limited to, Coumadin, NSAIDS, Ibuprofen, vitamin K, other) for 2 weeks (14 days) prior to the procedure. Willing to abstain from smoking, vaping, or the use of e-cigarettes for 1 year prior to and for the entire duration of participation in the study. Willing to abstain from the use of marijuana for 2 weeks prior to and for the duration of participation in the study. Able to read, understand, sign and date the informed consent document (English only). Exclusion Criteria: Pregnant or lactating. Pregnancy within 12 months prior to screening. Use within 24 hours preceding surgery of ibuprofen, acetaminophen, any other analgesics, anti-inflammatory products, or any products including herbals and supplements that could interfere with the clinical assessments of this study (other than drugs used for anesthesia). Allergy to tumescent anesthetic (lidocaine/epinephrine). Excessive subcutaneous fat in the treatment area (as determined by the treating investigator). 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. Severe solar elastosis. History of autoimmune disease (excluding Hashimoto's thyroiditis). Known hypersensitivity or adverse reaction to anesthetics. Known susceptibility to keloid formation or hypertrophic scarring. Cancerous or pre-cancerous lesions in the area to be treated. History or current diagnosis of cancer of any type (excluding skin cancer). History of uncontrolled cardiovascular disease (i.e. myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease, other). History, or current bleeding disorders (i.e. hemophilia or von Willebrand disease), or anticipated treatment with prescription anticoagulants. Possesses a surgically implanted electronic device (i.e. pacemaker). History of AIDs/HIV. Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years. Chronic hypoxia or dependence on supplemental oxygen. Participation in any other investigational study within 30 days prior to consent. Any surgical or transdermal neck/submental aesthetic procedures or plans to undergo any other aesthetic procedure during study participation. Such procedures include, but are not limited to, submentoplasty, liposuction, ultrasound, cryolipolysis, radiofrequency, and laser. History of or current injury to the head and neck or any area of the body being treated as a part of this study. Presence of more than mild platysmal banding as per the Geister, et al Validated Assessment Scale for Platysmal Bands. Subject requiring removal of adipose tissue prior index procedure. A family member of the investigator or sponsor; an employee of the investigator or sponsor. Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Phase I<br>Subjects will be treated with the Renuvion APR device in the neck and submental region. | Device: Renuvion APR Device<br>* The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.<br>|
| Experimental: Study Phase II<br>Subjects will be treated with the Renuvion APR device in the neck and submental region. | Device: Renuvion APR Device<br>* The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Day 180 Number of Participants With Improvement Measured By Independent Photographic Review | Improvement in the appearance of lax tissue in the neck and submental region at 6 months as determined by qualitative 2D photography assessment by blinded Independent Photographic Reviewers. Three experienced, blinded photographic reviewers performed a qualitative analysis/review of the pre-treatment and post-treatment sets of images of each subject in a blinded and randomized order. Each blinded reviewer chose which image was the post-treatment image. Success was correct post-treatment image selection by at least 2 of the 3 reviewers. The percentage of subjects with a correct post-treatment image selection was calculated. | 180-Day | 
| Subject Reported Pain - None to Moderate | The primary safety endpoint is the level of pain and discomfort after treatment as reported by the subject on an 11-point Numeric Rating Scale (NRS) through the 7-day follow-up visit where 0 is no pain and 10 is the most pain. Pain scores are classified as scores of 0 being no pain, 1 - 5 is minor pain, 6 - 7 is moderate pain, and 8 - 10 is severe pain. The primary safety objective is to demonstrate that the proportion of subjects with none-to- moderate pain exceeds the performance goal (PG). The performance goal is 55%. | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Submental, Neck