N/A
Completed N=44
Study of Over-The-Counter Use of Low Level Laser Light Therapy for Body Contouring of the Waist, Hips and Thighs
Circumference Reduction
Source: ClinicalTrials.gov NCT02167867 ↗
Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcomePrimary: Lay End User Ability to Correctly Choose Suitably Qualified Individuals to Get the ZERONA Z6 Treatments — 22 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lay End User Ability to Correctly Choose Suitably Qualified Individuals to Get the ZERONA Z6 Treatments |
22 | — |
| PRIMARY Lay End User Ability to Correctly Use the ZERONA Z6 and Follow the Treatment Directions. |
22 | — |
| PRIMARY Average Change in Inches of Total Circumference Measurements for the Treatment Subject Group After 2 Weeks of Treatment With the ZERONA Z6 |
-3.72 | <0.0001 sig |
Eligibility Criteria
Lay End Users
Inclusion Criteria
- 18 years of age or older
- Able to read and write English.
- Employees of the study test sites
Treatment Subjects
Inclusion Criteria
- 18 years of age or older
- Body Mass Index (BMI) <= 30 kg/m2
Exclusion Criteria
- Pregnancy
- Open wounds (sores, cuts, ulcers, etc.) on or around the waist, hips and/or thighs
- Currently have or are being treated for any cancerous growths on or around the waist, hips and/or thighs
Data sourced from ClinicalTrials.gov (NCT02167867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.