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

NCT ID: NCT05674292

Last Updated: 2023-09-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-11

Study Completion Date

2023-03-28

Brief Summary

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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

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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.

Conditions

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Circumference Reduction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Erchonia Violet Zerona Z6

405nm violet laser light therapy.

Group Type EXPERIMENTAL

Erchonia Violet Zerona Z6

Intervention Type DEVICE

405nm violet diode low level laser device

Interventions

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Erchonia Violet Zerona Z6

405nm violet diode low level laser device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erchonia Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tracey Hishon

Bloomfield Hills, Michigan, United States

Site Status

Jamie Thayer

Marquette, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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R-VZ6

Identifier Type: -

Identifier Source: org_study_id

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