Circumference Reduction
Conditions
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.
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.
Interventions
DEVICEErchonia Violet Zerona Z6
405nm violet diode low level laser device
Sponsors
Erchonia Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined Circumference Reduction in Inches of the Waist, Hips, and Bilateral Thighs | 2 weeks | Mean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erchonia Violet Zerona Z6 405nm violet laser light therapy.
Erchonia Violet Zerona Z6: 405nm violet diode low level laser device | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Erchonia Violet Zerona Z6 | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 2 Participants | — |
| Age, Categorical Between 18 and 65 years | 23 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 21 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erchonia Violet Zerona Z6 | Combined Circumference Reduction in Inches of the Waist, Hips, and Bilateral Thighs | -3.91 inches | Standard Deviation 1.649 |