Histological Study to Assess Safety and Efficacy of the TempSure Firm for Non-Invasive Lipolysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 3
- 主要终点
- Histology of Biopsy
研究概览
简要总结
This is a prospective, open-labeled, non-randomized, multi-center clinical study to collect safety and efficacy data on the TempSure Firm. The intended use of the TempSure device is to use the Firm handpieces for non-invasive lipolysis.
详细描述
Up to 12 subjects will be enrolled at up to 3 study centers. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive 1 treatment on the abdomen with the TempSure firm. Subjects will undergo abdominoplasty surgery at one of 4 predetermined timepoint after an abdomen treatment: day 0 (within 24 hours after treatment), 10 days (+/- 3 days), 20 days (+/- 3 days), or 30 days (+/- 7 days). This will be determined by the availability of the subject and/or an as needed basis and this will be decided by the Investigator and the Sponsor.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between 18 - 55 years old.
- •Willing to receive treatments with the TempSure® device and willing to have biopsies taken from a control site and the treatment area (biopsies are collected after the abdominal tissue flap is removed during abdominoplasty surgery)
- •Understand and accept obligation not to receive any other procedures on the treatment and control areas throughout the length of the study.
- •Understand and accept the obligation and able to be present for all study visits
- •Willing to comply with all requirements of the study and able to provide informed consent.
排除标准
- •Pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning to become pregnant prior to the end of the study.
- •Currently enrolled in an investigational drug or device trial, or has received an investigational drug or investigational device treatment(s) in the area to be treated (or designated control area) 6 months prior to entering this study (or at the discretion of the Investigator) .
- •Cuts, wounds, or infected skin on the area to be treated or designated control area
- •On local, oral, or systemic anesthetic agents.
- •Condition(s) or circumstance(s) that, in the investigators opinion, may put the subject at significant risk, may confound study results or may interfere significantly with subject participation.
结局指标
主要结局
Histology of Biopsy
时间窗: within 30 days (+/- 7 days) post treatment
Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 30 (+/- 3 days) after treatment. The samples were looked at from a qualitative standpoint to determine of whether the samples had signs of adipocyte injury and/or inflammatory tissue response, and if there was dermal/epidermal tissue injury (which was assessed by a qualified histologist).
次要结局
未报告次要终点