Prospective Clinical Study To Evaluate The Safety And Efficacy Of The MyEllevate® Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Physician Global Aesthetic Improvement Score (PGAIS)
研究概览
简要总结
The intended purpose of the MyEllevate® procedure used in this study is to assess the safety and efficacy of the procedure for soft tissue approximation and elevation of sub dermis and underlying muscle of the submentum & jawline.
详细描述
Subjects are to be enrolled in this clinical study if they are a healthy male or female between the age of 18 - 65. Up to 10 subjects will be enrolled at 2 study centers. All subjects will attend a screening/pre-procedure visit which may be performed on the same day as the procedure visit but no more than 30 days prior to their procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A healthy male or female between the age of 18 -
- •Must have any or all the following: visible platysma bands, glands and/or sagging in the submentum, jawline and/or neck.
- •Reads and understands English.
- •Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
- •Understands and accepts the obligation and is logistically able to be present for all visits.
- •Is willing to comply with all requirements of the study and sign the informed consent document.
排除标准
- •Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
- •Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study.
- •Have received any treatments or procedures (including injectables such as Botox or fillers) in the area to be treated at least 4 months prior to treatment.
- •Take antiplatelets, anticoagulants, thrombolytics, or anti-inflammatories.
- •Have an active localized or systemic infection.
- •Have an open wound in area being treated.
- •Have a significant systemic illness or an illness localized in area being treated.
- •Have had recent surgeries or problems in the treatment area (e.g. neck fracture, neck sprain, pinched nerve, spondylosis, arthritis in the neck).
- •Have a history of thrombophlebitis.
- •Have a history of heart failure or kidney disease.
- •Have a history of allergic reaction or intolerance to the anesthesia used during the procedure.
- •Have a history of poor wound healing.
- •Have a history of poor circulation.
- •Have a systemic autoimmune disease known to impair wound healing.
- •Have a history of keloid formation.
- •Currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study.
- •Has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
结局指标
主要结局
Physician Global Aesthetic Improvement Score (PGAIS)
时间窗: 30 days post last treatment
The physician will grade the improvement that they see at the 30 day follow up (30 days post treatment). They will grade them as one of the following: Very Much Improved, Much Improved, Improved, No Change, or Worsened.
次要结局
未报告次要终点