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

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

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.

Study Overview

• Status: Completed
• Conditions: Reduction of the Waist Circumference
• Intervention / Treatment: Device: YOLO TOUCH Low Level Laser

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • McMurray, Pennsylvania, United States, 15317
      • Burnett Sports Performance Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser therapy	Device: YOLO TOUCH Low Level Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of girth measurements for the waistline	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.	3 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Complications, device related adverse events during LLLT and device related adverse events post LLLT.	up to at day 50

Collaborators and Investigators

• Sponsor: Yolo Medical Inc.
• Investigators: Principal Investigator: Matthew Portz, M.D., Burnett Sports Perfomance Center

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: July 8, 2014
• First Submitted That Met QC Criteria: July 9, 2014
• First Posted (Estimate): July 10, 2014

Study Record Updates

• Last Update Posted (Estimate): July 10, 2014
• Last Update Submitted That Met QC Criteria: July 9, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: YTCSP-2013-YOLO-REDUCE