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

Circumference Reduction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05674292
• Other study ID #: R-VZ6
• Status: Completed
• Phase: N/A
• Start date: July 11, 2022
• Est. completion date: March 28, 2023

Study information

• Verified date: August 2023
• Source: Erchonia Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 28, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Circumference Reduction

Intervention

Device:
• Erchonia Violet Zerona Z6
405nm violet diode low level laser device

Locations

Country	Name	City	State
United States	Tracey Hishon	Bloomfield Hills	Michigan
United States	Jamie Thayer	Marquette	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Erchonia Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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