An Evaluation of the Effect of the Erchonia Corporation Violet Zerona® Z6 for Body Contouring

Not Applicable

Completed

• Conditions: Circumference Reduction
• Interventions: Device: Erchonia Violet Zerona Z6

• 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.

Study Timeline

• Study Start: 2022-07-11
• Study First Submitted: 2022-12-30
• Study First Submitted QC: 2022-12-30
• Study First Posted: 2023-01-06
• Primary Completion: 2023-03-28
• Study Completion: 2023-03-28
• Status Verified: 2023-08
• Results First Submitted: 2023-08-17
• Results First Submitted QC: 2023-08-17
• Last Update Submitted: 2023-08-17
• Results First Posted: 2023-09-13
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• BMI is 30 or less
• 18 years of age or older

Exclusion Criteria

• 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

Arm && Interventions

Group	Intervention	Description
Erchonia Violet Zerona Z6	Erchonia Violet Zerona Z6	405nm violet laser light therapy.

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.

Trial Locations

Locations (2)

Jamie Thayer; 🇺🇸 Marquette, Michigan, United States

Tracey Hishon; 🇺🇸 Bloomfield Hills, Michigan, United States