Safety and Effectiveness of the "YOLO TOUCH" LLLT for Circumference Reduction of the Waistline
Completed · Not applicable
Conditions studied: Reduction of the Waist Circumference
In brief
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.
Key facts
- Study ID
- NCT02187237
- Run by
- Yolo Medical Inc.
- People needed
- 50
- Starts
- 2013-09-01
- Expected to finish
- 2014-01-01
- Last updated by the study team
- 2014-07-10
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Burnett Sports Performance Center — McMurray, Pennsylvania, United States
Full record on ClinicalTrials.gov
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