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

NCT ID: NCT02187237

Last Updated: 2014-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-01-31

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.

Conditions

Reduction of the Waist Circumference

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Laser therapy

Group Type: EXPERIMENTAL

YOLO TOUCH Low Level Laser

Intervention Type: DEVICE

Interventions

YOLO TOUCH Low Level Laser

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yolo Medical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Portz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Burnett Sports Perfomance Center

Locations

Burnett Sports Performance Center

McMurray, Pennsylvania, United States

Countries

United States

Other Identifiers

YTCSP-2013-YOLO-REDUCE

Identifier Type: -

Identifier Source: org_study_id