Study of Over-The-Counter Use of Low Level Laser Light Therapy for Body Contouring of the Waist, Hips and Thighs

Body Contouring Clinical Trial

Official title:

Evaluation of Efficacy, Usability and Labeling Comprehension for Over-the-Counter Use of the Erchonia Corporation ZERONA® Z6 for Body Contouring of the Waist, Hips and Thighs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02167867
• Other study ID #: EC_Z6_OTC
• Status: Completed
• Phase: N/A
• First received: June 17, 2014
• Last updated: October 15, 2014
• Start date: July 2014
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Erchonia Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the ability of the lay end user to understand the information contained in the User's Guide; to correctly identify patients who are suitably qualified to receive treatment; and to correctly administer the treatment with the Erchonia ZERONA® Z6 for circumference reduction of the waist, hips and thighs in an over-the-counter setting.

Description:

The Erchonia ZERONA® Z6 is a low level laser light therapy device that has been approved by the United States Food and Drug Administration (FDA) for use by licensed medical professionals to help to reduce the circumference of the hips, waist and thighs.

This study is to see if the Erchonia ZERONA® Z6 can be used by lay (non-medical professional) people to treat others to help to reduce the circumference of the hips, waist and thighs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Body Mass Index (BMI) of 30 or less

• Able to read and write English.

Exclusion Criteria:

• Pregnancy

• Presence of open wounds on or around the treatment area of the waist, hips and thighs

• Have or are being treated for any cancerous growth on or around the treatment area of the waist, hips and thighs

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Contouring

Intervention

Device:
• ZERONA Z6
20 minutes of treatment to the front side of the waist, hips and thighs and 20 minutes of treatment to the back side of the waist, hips and thighs.

Locations

Country	Name	City	State
United States	Lifetime Fitness	Colorado Springs	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Erchonia Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lay end user ability to correctly identify suitably qualified individuals to receive the ZERONA Z6 treatments	The percentage of lay end users who correctly evaluate and select fully qualified individuals to receive the ZERONA Z6 treatment is calculated.	Baseline	No
Primary	Lay end user ability to correctly operate ZERONA Z6 and administer the treatment such that circumference reduction comparable to that attained for active treatment subjects during the prior efficacy clinical study trial is attained	This primary measure is evaluated as follows: Percentage of lay end users who correctly administer the treatments with the ZERONA Z6 according to the treatment administration protocol; and; The average change in combined circumference measurements across the two-week treatment administration period for all subjects will be calculated. A decrease of 3.52 inches or more will be considered supportive of study efficacy success.	Baseline and two weeks	No
Primary	Lay end user understanding of the indication for use and the specific warnings and cautions pertaining to use of ZERONA Z6.	The percentage of correct responses to the respective items in a questionnaire developed to assess Lay End User understanding of the User's Manual will be calculated.	Baseline	No
Secondary	Lay end user ability to correctly assemble the ZERONA Z6 device	The percent of lay end users who correctly assemble the ZERONA Z6 device according to the device assembly steps contained in the User's Guide will be calculated.	Baseline	No