Skip to main content
OpenTrials
Completed

NCT Number: NCT05674292

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Circumference Reduction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tracey Hishon, Bloomfield Hills, Michigan, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erchonia Violet Zerona Z6

Device

405nm violet diode low level laser device

Primary outcomes

  1. Combined Circumference Reduction in Inches of the Waist, Hips, and Bilateral Thighs

    Time frame: 2 weeks

    Mean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation.

Sponsors and collaborators

Lead sponsor

Erchonia Corporation

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 6, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.