NCT05773924招募中不适用
Evaluation of Efficacy and Safety of the triLift™ System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The Global Aesthetic Improvement scale (GAI)
研究概览
简要总结
Single center, single-arm, prospective, open Label with Before & After Study Design.
详细描述
Single center, single-arm, prospective, open Label with Before & After Study Design. The control group will be the subjects before the triLift™ treatment protocol and the experimental group will consist of the same subjects after completion of the triLift™ treatment protocol.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is willing and able to read, understand, and sign the informed consent.
- •Healthy male or female aged 35 - 55 years.
- •Fitzpatrick skin type 1-
- •Subject is capable of reading, understanding, and following instructions of the procedure to be applied.
- •Subject is able and willing to comply with the treatment. Women in childbearing age who is willing to conduct a pregnancy test prior to each treatment.
排除标准
- •Pregnant, lactating, or plans to become pregnant during the study period or had given birth less than 6 months ago.
- •Concurrent participation in any other study.
- •Subject has a pacemaker or internal defibrillator, implanted neurostimulators or any other internal electric device or patient who had an implant in the past.
- •Subject has metal or other implants in the treatment area (Not including dental fillings, implants and crowns).
- •Subject has significant concurrent skin conditions affecting areas to be treated such as sores, bleeding, skin fragility, eczema or psoriasis.
- •Subject has burned, blistered, irritated, or sensitive skin due to excessive fresh tanning in areas to be treated or is unlikely to refrain from excessive tanning during the study.
- •Subject has used oral isotretinoin (Accutane® or Roaccutan®) within 6 months prior to study.
- •Subject has used topical retinoids in the past 1 month.
- •History of systemic cancer; premalignant skin lesion or skin concern treatment area.
- •Concurrent conditions such as epilepsy, autoimmune, pulmonary or cardiac disorders.
- •Poorly controlled endocrine disorders such as diabetes.
- •Impaired immune system due to immunosuppressive diseases such as HIV or AIDS, or use of immunosuppressive medications.
- •History of collagen disorders, keloid formation or abnormal wound healing.
- •Takes or has taken medications, herbal preparations, food supplements or vitamins that might cause fragile skin or impaired skin healing.
- •Subject has used oral steroids in the past 6 months.
- •Subject has used topical steroids in the past 3 months.
- •History of bleeding coagulopathies or use of anticoagulants.
- •Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen containing agents) one week before and after each treatment session prior to treatment.
- •Subjects who cannot feel heat to give proper treatment feedback. (nerve damage, etc.)
- •Mental disorders that in the opinion of the Investigator would interfere with the ability to comply with the study requirements.
- •Subject has any other medical condition that in the opinion of the Investigator warrants exclusion from this study.
结局指标
主要结局
The Global Aesthetic Improvement scale (GAI)
时间窗: 4 months
The Global Aesthetic Improvement scale (GAI) - Success is defined as an improvement of at least 1 point on the GAI scale assessed by the investigator, at the end of the treatment protocol as compared to baseline.
次要结局
- 3D images(4 months)
- Comfort assessment(3 months)
- Subject level of Satisfaction(4 months)
研究者
研究点 (1)
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