NCT05674292

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2023

Completed
6 months until next milestone

Results Posted

Study results publicly available

September 13, 2023

Completed
Last Updated

September 13, 2023

Status Verified

August 1, 2023

Enrollment Period

9 months

First QC Date

December 30, 2022

Results QC Date

August 17, 2023

Last Update Submit

August 17, 2023

Conditions

Circumference Reduction

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Erchonia Violet Zerona Z6

EXPERIMENTAL

405nm violet laser light therapy.

Device: Erchonia Violet Zerona Z6

Interventions

Erchonia Violet Zerona Z6DEVICE

405nm violet diode low level laser device

Erchonia Violet Zerona Z6

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnant
  • Open wounds (sores, cuts, ulcers, etc.)
  • Individuals with or being treated for any cancerous growth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tracey Hishon

Bloomfield Hills, Michigan, 48302, United States

Location

Jamie Thayer

Marquette, Michigan, 49855, United States

Location

Results Point of Contact

Title
Clinical Affairs Manager
Organization
Erchonia Corporation
tsammons@erchonia.com
8882420571

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2022

First Posted

January 6, 2023

Study Start

July 11, 2022

Primary Completion

March 28, 2023

Study Completion

March 28, 2023

Last Updated

September 13, 2023

Results First Posted

September 13, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)