Clinical trial NCT02187237: Safety and Effectiveness of the "YOLO TOUCH" LLLT for Circumference Reduction of the Waistline
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reduction of the Waist Circumference
Lead sponsor: Yolo Medical Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction of girth measurements for the waistline
timeFrame: 3 weeks
Secondary outcomes:
measure: Complications, device related adverse events during LLLT and device related adverse events post LLLT.
timeFrame: up to at day 50
Other outcomes:
Locations:
city: McMurray
country: United States
facility: Burnett Sports Performance Center
state: Pennsylvania
Study officials:
affiliation: Burnett Sports Perfomance Center
name: Matthew Portz, M.D.
role: PRINCIPAL_INVESTIGATOR
References: