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

Reduction of the Waist Circumference Clinical Trial

— REDUCE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02187237
• Other study ID #: YTCSP-2013-YOLO-REDUCE
• Status: Completed
• Phase: N/A
• First received: July 8, 2014
• Last updated: July 9, 2014
• Start date: September 2013
• Est. completion date: January 2014

Study information

• Verified date: July 2014
• Source: Yolo Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Reduction of the Waist Circumference

Intervention

Device:
• YOLO TOUCH Low Level Laser

Locations

Country	Name	City	State
United States	Burnett Sports Performance Center	McMurray	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Yolo Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complications, device related adverse events during LLLT and device related adverse events post LLLT.		up to at day 50