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

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.

Study Overview

• Status: Completed
• Conditions: Circumference Reduction
• Intervention / Treatment: Device: Erchonia Violet Zerona Z6

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Bloomfield Hills, Michigan, United States, 48302
      • Tracey Hishon
    • Marquette, Michigan, United States, 49855
      • Jamie Thayer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erchonia Violet Zerona Z6; 405nm violet laser light therapy.	Device: Erchonia Violet Zerona Z6; 405nm violet diode low level laser device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combined Circumference Reduction in Inches of the Waist, Hips, and Bilateral Thighs	Mean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation.	2 weeks

Collaborators and Investigators

• Sponsor: Erchonia Corporation

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Actual): March 28, 2023
• Study Completion (Actual): March 28, 2023

Study Registration Dates

• First Submitted: December 30, 2022
• First Submitted That Met QC Criteria: December 30, 2022
• First Posted (Actual): January 6, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: R-VZ6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No