Study to Collect Post-Market Data on Non-Invasive Subcutaneous Fat Reduction in the Submental, Inner Thigh and Back/Bra Areas With the CoolSculpting Elite System
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Number of Participants with Device and/or Procedure-Related Adverse Events (AEs)
研究概览
简要总结
The primary objective of this protocol is the continued collection of data specific to the submental, inner thigh and back/bra body areas with CoolSculpting Elite. The study aims to collect post-market safety data while allowing for the collection of standardized photos and satisfaction questionnaires after treatment with commercial treatment parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant has clearly visible fat on the submental, bilateral inner thigh or bilateral back/bra areas, which in the investigator's opinion, is appropriate for treatment with CoolSculpting Elite.
- •Participant has not had weight change exceeding 5% of body weight in the preceding month.
排除标准
- •Participant has had a recent surgical procedure in the area of intended treatment within the previous 6 months.
- •Participant has had previous surgical or invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
- •Participant has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the previous 12 months.
研究组 & 干预措施
Cohort A: Submental
Participants will receive applications of the CoolSculpting Elite System in the submental body area.
干预措施: CoolSculpting Elite System (Device)
Cohort B: Inner Thigh
Participants will receive applications of the CoolSculpting Elite System in the inner thigh (bilateral) body area.
干预措施: CoolSculpting Elite System (Device)
Cohort C: Back/Bra
Participants will receive applications of the CoolSculpting Elite System in the back/bra (bilateral) body area.
干预措施: CoolSculpting Elite System (Device)
结局指标
主要结局
Number of Participants with Device and/or Procedure-Related Adverse Events (AEs)
时间窗: Up to Approximately 6 Months
Frequency of device and procedure-related AEs including serious device-related adverse events (SADEs), will be analyzed per cohort.
次要结局
未报告次要终点