An Evaluation of the Effect of the Erchonia Corporation Violet Zerona® Z6 for Body Contouring
- Conditions
- Circumference Reduction
- Registration Number
- NCT05674292
- Lead Sponsor
- Erchonia Corporation
- Brief Summary
The purpose of this clinical study is to determine the effectiveness of the Erchonia® Violet Zerona Z6 (manufactured by Erchonia Corporation (the Company), an over-the-counter (OTC) laser device, in providing noninvasive body circumference reduction.
- Detailed Description
The clinical study is an open-label non-inferiority design to evaluate the efficacy of the Erchonia® Violet Zerona Z6, an over-the-counter (OTC) laser device, in providing noninvasive circumference reduction. The clinical study protocol is based on the protocol for the clinical study whose results were submitted in support of clearance of the predicate device, the Erchonia® Zerona® Z6 OTC.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- BMI is 30 or less
- 18 years of age or older
- Pregnant
- Open wounds (sores, cuts, ulcers, etc.)
- Individuals with or being treated for any cancerous growth
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Combined Circumference Reduction in Inches of the Waist, Hips, and Bilateral Thighs 2 weeks Mean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (2)
Tracey Hishon
🇺🇸Bloomfield Hills, Michigan, United States
Jamie Thayer
🇺🇸Marquette, Michigan, United States
Tracey Hishon🇺🇸Bloomfield Hills, Michigan, United States