A RandomizEd DoUble Blinded Controlled Study to Evaluate the Safety and Effectiveness of the "YOLO TOUCH" Low Level Laser Therapy (LLLT) for Circumference Reduction of he Waistline - REDUCE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reduction of girth measurements for the waistline
研究概览
简要总结
The YOLO TOUCH consists of a console and multi-probes that are placed on the treatment area that emit laser light to reduce the circumference waistline.
详细描述
The YOLO TOUCH device is class II device intended for use in circumference reduction of the waist as a non-invasive, non-thermal, and low energy laser. Typical area of the body for use with the YOLO TOUCH is the abdominal area.
The YOLO TOUCH low-level therapy device consists of a main console and 8 multi-probes that are constructed so that each probe contains 12 laser emission diode sources at a power output of 35mW per diode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is an adult ≥ 18 years old and <65 years of age
- •Subject has maintained a stable weight for the past 6 months (variation no greater than 10 lbs. from "usual weight")
- •Subject is willing to maintain current diet and exercise regimen for the duration of the study.
- •Subject is willing and able to provide written informed consent.
- •Subject is willing to return for all scheduled and required visits.
- •Subject is willing to comply with post-laser treatment cardiovascular exercise.
- •Subject is willing to comply with food and fluid requirements pre-treatment and post-treatment.
排除标准
- •Subject is on an active weight control regimen.
- •Subject has a pacemaker.
- •Subject has a history of epilepsy.
- •Subject has a history of any type of cancer, including skin cancer.
- •Subject had a prior surgical intervention for body sculpting/weight loss such as liposuction, abdominoplasty, gastroplasty, lap band surgery, etc.
- •Subject has a medical, physical, or other contraindications for body sculpting/weight loss.
- •Subject has an active infection, wound or other external trauma to the areas to be treated with the laser.
- •Subject is pregnant, breast feeding, or planning pregnancy prior to study end.
- •Subject is participating in any treatment other than the study procedure (existing or new) to promote body contouring and/or weight loss during the course o the study participation.
- •Subject is participating in another research study of a device, medication, biologic, or other agent within 30 days or could, in the opinion of the investigator, affect the results of this study.
研究组 & 干预措施
Laser therapy
干预措施: YOLO TOUCH Low Level Laser (Device)
结局指标
主要结局
Reduction of girth measurements for the waistline
时间窗: 3 weeks
Reduction of one (1.0) inch of girth measurement in the average of three circumference measurements for the waistline from baseline to after completion of the three (3) week study procedure (i.e., after nine (9) twenty (20) minute laser treatments - three (3) per week for three (3) weeks.
次要结局
- Complications, device related adverse events during LLLT and device related adverse events post LLLT.(up to at day 50)