NCT04050033已完成不适用
Clinical Study to Evaluate the Performance of Evoke Radiofrequency Device for Improvement of Skin Appearance
InMode MD Ltd.6 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年6月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Number of participants with Change in Skin Appearance
研究概览
简要总结
The aim of the study is to evaluate the safety, efficacy, patient comfort and patient satisfaction after Evoke treatment
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Signed informed consent to participate in the study.
- •Female and male subjects, 35 - 75 years of age at the time of enrolment
- •If female, not pregnant, lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence).
- •In addition, negative urine pregnancy test as tested before each treatment and at the last visit for women with childbearing potential (e.g. not menopause).
- •General good health confirmed by medical history and skin examination of the treated area.
- •Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.
- •The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods for the last 6 months and during the entire study period.
排除标准
- •- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
- •Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance, unless deep enough in the periostal plane.
- •Current or history of skin cancer, or current condition of any other type of cancer, or premalignant moles.
- •Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
- •Pregnancy and nursing.
- •Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
- •Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
- •Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction.
- •Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
- •History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
- •History of bleeding coagulopathies or use of anticoagulants in the last 10 days.
- •Any surgery in treated area within 3 months prior to treatment.
- •Six months delay is required if other recent treatments like light, CO2 laser or RF were performed on the same area.
- •Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
- •As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient
结局指标
主要结局
Number of participants with Change in Skin Appearance
时间窗: 1 month, 3 month, 6 months
Picture evaluation by blinded investigators.
Evaluate rate of Change in Skin Appearance using 3D Photographic analysis
时间窗: 1 month, 3 month, 6 months
3D Photographic analysis will be conducted using QuantifiCare System
Evaluate changes in skin using VivoSight Optical Coherence Tomography (OCT) software
时间窗: 1 month, 3 month, 6 months
Non-invasive in vivo skin imaging will be taken with the VivoSight Optical Coherence Tomography (OCT).
Evaluate changes in skin appearance comparing photographs using Mechanical Turk (MTurk). The pictures will be sent through the system and evaluated by crowd workers.
时间窗: 1 month, 3 month, 6 months
The pictures will be sent through the system and evaluated by crowd workers.
次要结局
- Evaluate histological changes to treatment area skin(3 Months)
- Evaluate Subject assessment of improvement and satisfaction(1 Month, 3 Months, 6 Months)
- Evaluate Investigator assessment of the skin appearance improvement(1 Month, 3 Months, 6 Months)
研究者
研究点 (6)
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