Safety and Effectiveness of the "YOLO TOUCH" LLLT for Circumference Reduction of the Waistline (REDUCE)

Yolo Medical

Status

Completed

Conditions

Reduction of the Waist Circumference

Treatments

Device: YOLO TOUCH Low Level Laser

Study type

Interventional

Funder types

Industry

Identifiers

NCT02187237

YTCSP-2013-YOLO-REDUCE

Details and patient eligibility

About

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.

Full description

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.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.