A Multi-Center, Prospective, Randomized, Single-Blind, Controlled Clinical Trial Comparing VASER-Assisted Lipoplasty and Suction-Assisted Lipoplasty.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 3
- 主要终点
- Investigators aim to assess outcomes associated with the two different methods to determine if one technology/technique offers superior results compared to the other.
研究概览
简要总结
This study is being done to compare two commonly available types of body contouring, VASER-Assisted Lipoplasty (VAL) and Suction-Assisted Lipoplasty (SAL), and to decide if one procedure is preferred by patients and/or surgeons over the other. Participants will have VAL on one side of their body and SAL on the opposite side.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •give voluntary, signed informed consent in accordance with institutional policies
- •be between the ages of 18-50 years old
- •Be willing and able to appear for all scheduled, post-operative visits with their doctor
- •Have moderate to good skin tone
- •Have excess fatty tissue in the arms, medial thighs, lateral thighs, or back where the extra tissue is expected to be composed of adipose tissue.
- •Have a body mass index between 20-30
- •Are non-smokers
排除标准
- •under the age of 18
- •over the age of 50
- •are undergoing boy contouring for reconstruction following injury or disease are deemed inappropriate candidates for surgery due to medical or mental health reasons
- •are concurrently being treated with other investigational agents or have participated in an investigational study within 60 days prior to surgery
- •elect not to participate in the study
研究组 & 干预措施
SAL
Each patient will have Suction Assisted Lipoplasty procedure on one side of the body (this will be considered the control side)
干预措施: Suction-assisted Lipoplasty (Device)
VAL
Each patient will have VASER- assisted lipoplasty on the opposite side of the body. This will be the comparison side.
干预措施: VASER-assisted lipoplasty (Device)
结局指标
主要结局
Investigators aim to assess outcomes associated with the two different methods to determine if one technology/technique offers superior results compared to the other.
时间窗: 6 months
次要结局
- To assess the difference in patients' post-operative pain level between the SAL side and the VAL side(6 months)
- To assess the difference in patients' post-operative sensation level between the SAL side and the VAL side(6 months)
- To assess the difference in post-operative patient preference between the SAL side and the VAL side(6 months)
- To assess the difference in post-operative ecchymosis between the SAL side and the VAL side(6 months)
- To assess the difference in post-operative skin retraction between the SAL side and the VAL side(6 months)
- To assess the difference in the amount of aspirate blood content between the SAL side and the VAL side(1 day)
- To assess any difference in the amount or degree of complications using the the SAL procedure versus the VAL procedure(6 months)
- To assess the difference in the time required for the SAL procedure versus the time required for the VAL procedure.(6 months)