NCT01273961已完成不适用
Radiofrequency Magnetic Induction Device for Use in Non-Invasive Body Contouring
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Improvement in cosmesis
研究概览
简要总结
The purpose of this pilot research study is to collect information on the safety and effectiveness of an experimental device used to treat and improve the appearance of the skin by reducing the visibility of wrinkles and by reducing the looseness of skin.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female 21 to 70 years old,
- •For females, at least 9 months post-partum,
- •Clinically appreciable skin laxity on the abdomen, thigh, upper arms or neck as determined by the study investigator,
- •For females, post-menopausal, surgically sterilized, or using a medically accepted form of birth control for at least 3 months prior to the study,
- •Apparently healthy,
- •Informed consent signed by the subject.
排除标准
- •History of skin hypersensitivity,
- •Current skin disorder (e.g. keloid scarring) or infection (e.g., herpes simplex),
- •Use of non-steroidal anti-inflammatory drugs within past 2 weeks,
- •Suffering from hormonal imbalance which may affect weight or cellulite,
- •Subjects with pacemakers, internal defibrillators or electronically, magnetically, and mechanically activated implants,
- •Subjects with implanted medical prostheses (such as clips, pins or plates) proximal to the treatment site,
- •The current or recent use (within the past 12 months) of isotretinoin,
- •Pregnancy or breast feeding,
- •Infectious diseases (such as HIV) present,
- •Are a tobacco smoker,
- •Insulin dependent diabetic subjects,
- •Oxygen dependent subjects,
- •Subjects with severe chronic illness, scleroderma, or lupus,
- •Subjects with open sores or scars in the treatment region, or
- •Subjects with ischemia in the treatment region.
结局指标
主要结局
Improvement in cosmesis
时间窗: 1 and 3 months
Improvement in cosmesis will be assessed by scoring photographs taken before and 1 and 3 months after treatment. Circumference changes will be measured and compared.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Investigation of Radiofrequency Device for Treatment of Wrinkles and RhytidesLaxity of SkinNCT01279226Rocky Mountain Biosystems, Inc.40
终止
不适用
Use of Implanted Microstimulators for Decreasing Spasticity and Improving Motion Following Spinal Cord InjurySpinal Cord Injury at C5-C7 Level With Incomplete LesionNCT00781833The Alfred E. Mann Foundation for Scientific Research1
Unknown
不适用
Safety and Efficacy of Radio Frequency for the Treatment of Mild to Severe Inflammatory AcneInflammatory Acne VulgarisNCT05830968InMode MD Ltd.42
已完成
不适用
Clinical Study To Evaluate Paired Treatment With An Alexandrite Laser And Radiofrequency Microneedling For Facial AgingWrinkleDyschromiaPhotoagingNCT05388604Cynosure, Inc.42
Unknown
不适用
Safety and Efficacy of Bi-Polar Radiofrequency for the Treatment of Erectile DysfunctionErectile DysfunctionNCT06299332InMode MD Ltd.20