NCT04842110已完成不适用
A Prospective, Controlled, Standardized, Multi-center, Single-treatment, Single- Arm Evaluation of the EonTM FR 1064 nm Device to Reduce Abdominal Fat
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Photographic Evaluations as a Measure of Effectiveness
研究概览
简要总结
This is a marketing study intended to provide additional data for marketing purposes for the eon™ FR is FDA 510(k) which has been cleared for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. This device is intended for individuals with a Body Mass Index (BMI) of 30 kg/m2 or less.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is a healthy male or female > 18 years or older seeking treatment for unwanted fat in the abdomen.
- •Subject must be able to read, understand and sign the Informed Consent Form (ICF) in English.
- •Subject has sufficient thickness (≥ 25 mm) of adipose tissue on the abdomen area.
- •Study subjects must agree to maintain their current diet and weight (not gaining or losing greater than ±5 lbs.
- •Subject must be willing and able to adhere to the treatment and follow-up visit schedule.
- •Subject must be willing to have limited sun exposure for the duration of the study, including the follow-up period.
- •Subject is willing to have photographs and ultrasound measurements taken of the treated area, which will be de-identified in evaluations and may be used in presentations and/or publications.
- •Female subjects must be using medically acceptable form of birth control during the entire course of the study or may be post-menopausal, surgically sterilized.
排除标准
- •Aesthetic fat reduction procedure in the treatment area within the previous year.
- •Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in last 6 months
- •Unstable weight within the last 6 months (+ or - 3% weight change in the prior six months)
- •Subject has an infection, dermatitis or a rash in the treatment area.
- •Subject has tattoos or jewelry in the treatment area or within the treatment area site or photography frame.
- •Subject has a history of keloid scarring, hypertrophic scarring or of abnormal wound healing.
- •Subject has a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
- •Subject has a history of a known bleeding disorder.
- •Subject has a known photosensitivity to the study laser wavelength, history of ingesting medications known to induce photosensitivity, or history of seizure disorders due to light.
- •Subject has known collagen, vascular disease or scleroderma.
- •Subject has undergone a surgery or procedure in the treatment area within 6 months of treatment, which is still healing.
- •Subject suffers from significant concurrent illness, such as insulin-dependent diabetes, peripheral vascular disease or peripheral neuropathy.
- •Subject is undergoing systemic chemotherapy for the treatment of cancer.
- •Subject is using gold therapy for disorders such as rheumatologic disease or lupus.
- •Subject has participated in a study of another device or drug within three months prior to enrollment or during the study.
- •As per the investigator's discretion, the subject has any physical or mental condition which might make it unsafe for the subject to participate in this study.
- •Subject has ongoing use of steroids or secondary rheumatoid drugs.
- •Subject is actively taking psychotropic medications.
结局指标
主要结局
Photographic Evaluations as a Measure of Effectiveness
时间窗: 12 Weeks
Photographs of the treatment area will be obtained at baseline and 12 weeks post treatment and be evaluated by blinded independent readers to correctly identify pre-treatment (baseline) photographs compared to 12 weeks post treatment photographs in order to determine effectiveness of device.
次要结局
- Subject Satisfaction(12 weeks)
- Change in Adipose Layer Thickness(12 weeks)
研究者
研究点 (2)
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