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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Apyx Medical
- 入组人数
- 82
- 试验地点
- 6
- 主要终点
- Day 180 Number of Participants With Improvement Measured By Independent Photographic Review
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Study Phase I
Subjects will be treated with the Renuvion APR device in the neck and submental region.
干预措施: Renuvion APR Device (Device)
Study Phase II
Subjects will be treated with the Renuvion APR device in the neck and submental region.
干预措施: Renuvion APR Device (Device)
结局指标
主要结局
Day 180 Number of Participants With Improvement Measured By Independent Photographic Review
时间窗: 180-Day
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.
Subject Reported Pain - None to Moderate
时间窗: Day 7
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%.
次要结局
未报告次要终点