Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Knees
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ulthera, Inc
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Improvement in overall lifting and tightening of knee skin laxity.
研究概览
简要总结
Enrolled subjects will receive one bilateral Ulthera® treatment on the knees. Up to 30 subjects will be enrolled. Study photos will be obtained prior to study treatment, immediately following study treatment, and at each post-treatment follow-up visit. Follow-up visits will occur at 90 and 180 days post-treatment.
详细描述
This pilot study is a prospective, single-center clinical trial of the Ulthera® System for treating skin laxity on the knees. Global Aesthetic Improvement Scale scores and Patient Satisfaction questionnaires will be obtained at each follow-up visit.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, aged 30 to 65 years.
- •Subject in good health.
- •Mild to moderate skin laxity around the knees.
- •Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
排除标准
- •Presence of an active systemic or local skin disease that may affect wound healing.
- •Excessive subcutaneous fat around the knees.
- •Excessive skin laxity around the knees.
研究组 & 干预措施
Ulthera® treatment of the knees
Bilateral treatment of the knees using the Ulthera® System
干预措施: Ulthera® System (Device)
结局指标
主要结局
Improvement in overall lifting and tightening of knee skin laxity.
时间窗: 90 and 180 days post-treatment
Assessed based on Principal Investigator assessment using the Global Aesthetic Improvement Scale.
次要结局
- Overall improvement in skin laxity.(90 and 180 days post-treatment)