NCT03898830已完成不适用
A Prospective, Controlled, Standardized, Multi-center, Single-treatment, Single-arm Evaluation of the Eon™ FR 1064 nm Device to Reduce Abdominal Fat With a 12-week Observation Interval to Assess Safe Fat Reduction
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Photographic Evaluations as a Measure of Effectiveness
研究概览
简要总结
This study evaluates the treatment of subjects with the eon™ FR 1064 nm device in a single session to thermally induce apoptosis in adipose tissue.
详细描述
This study evaluates the treatment of subjects between 18-60 with the eon™ FR 1064 nm device in a single session to thermally induce apoptosis in adipose tissue in the abdomen.
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
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) of 30 kg/m2 or less.
- •Healthy male or female between the ages of 21 and
- •Had, at least 25 mm thickness adipose tissue on abdomen.
- •Able to read, understand and sign the Informed Consent Form (ICF).
- •Willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
- •Willing to have limited sun exposure for the duration of the study, including the follow-up period.
- •Willing to have photographs and ultrasound measurements taken of the treated area, which could be used de-identified in evaluations and could be used de-identified in presentations and/or publications.
- •Female subjects were either post-menopausal, surgically sterilized, or used a medically acceptable form of birth control during the entire course of the study.
- •Female subjects with child bearing potential were willing to take a urine pregnancy test and the result must be negative.
- •Agreed to maintain their current diet and exercise habits and not be specifically trying to lose weight.
排除标准
- •Aesthetic fat reduction procedure in the treatment area within the previous year.
- •Age less than 21 or greater than 60 years old.
- •Female subject pregnant or planning to become pregnant during the study duration,
- •Had an infection, dermatitis or a rash in the treatment area.
- •Had tattoos or jewelry in the treatment area.
- •Had a history of keloid scarring, hypertrophic scarring or of abnormal wound healing.
- •Had a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
- •Had a history of a known bleeding disorder.
- •Had a known photosensitivity to the study laser wavelength, history of ingesting. medications known to induce photosensitivity, or history of seizure disorders due to light.
- •Had known collagen, vascular disease or scleroderma.
- •Underwent a surgery or procedure in the treatment area within 6 months of treatment, which is still healing.
- •Had underwent a fat reduction procedure in the treatment area within the past 12 months.
- •Had a significant concurrent illness, such as insulin-dependent diabetes, peripheral vascular disease or peripheral neuropathy.
- •Underwent systemic chemotherapy for the treatment of cancer.
- •Used gold therapy for disorders such as rheumatologic disease or lupus.
- •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 had any physical or mental condition which might make it unsafe for the subject to participate in this study.
- •Concurrent use of steroids or secondary rheumatoid drugs.
- •Prior liposuction or a tummy tuck in the study area.
研究组 & 干预措施
eon™ FR 1064 nm device
Experimental
Patient will be treated with the eon™ FR 1064 nm device
干预措施: eon™ FR 1064 nm device (Device)
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
- Ultrasound Measurement to Evaluate Reduction in Adipose Layer Thickness(12 weeks)
- Circumferential Measurements to Evaluate Reduction in Adipose Layer Thickness(12 weeks)
- Subject Questionnaire to determine Subject Satisfaction(12 weeks)
研究者
研究点 (3)
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