Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening the Buttocks and Thighs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ulthera, Inc
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Overall lifting and tightening of the buttocks and thighs.
研究概览
简要总结
Up to 30 subjects will be enrolled. Enrolled subjects will receive an Ulthera® treatment to one side of the body, treating the lateral buttock region. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
详细描述
This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve buttock and thigh skin laxity. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, age 30 to 65 years.
- •Subject in good health.
- •Skin laxity in the buttocks and thighs.
- •Understands and accepts the obligation not to undergo any other procedures in the areas to be treated and/or weight loss through the follow-up period.
- •Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
- •Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history: a) Postmenopausal for at least 12 months prior to study; b) Without a uterus and/or both ovaries; or c) A bilateral tubal ligation at least six months prior to study enrollment.
排除标准
- •Presence of an active systemic or local skin disease that may affect wound healing.
- •BMI equal to or greater than
- •Excessive subcutaneous fat in the buttocks and thighs.
- •Excessive skin laxity in the buttocks and thighs.
- •Significant weight fluctuation (±10 lbs) in the past 6 months.
- •Taking weight-loss medications/supplements.
- •Surgical or non-surgical treatments to the target areas in the last 12 months, e.g., liposuction.
- •Inability to understand the protocol or to give informed consent.
研究组 & 干预措施
Ulthera-treated subjects
All enrolled subjects will receive one Ultherapy treatment to one side of the body in the lateral buttock region. Following study completion, subjects may elect to receive a balancing treatment to the other side of the body.
干预措施: Ulthera System Treatment (Device)
结局指标
主要结局
Overall lifting and tightening of the buttocks and thighs.
时间窗: 90 days post-treatment
As determined by a masked, qualitative assessment of photographs at three months post-treatment compared to baseline.
次要结局
- Overall aesthetic improvement.(90 and 180 days post-treatment.)
- Overall subject satisfaction.(90 and 180 days post-treatment)