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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erchonia Violet Zerona Z6 | Experimental | 405nm violet laser light therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erchonia Violet Zerona Z6 | Device | 405nm violet diode low level laser device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tracey Hishon | Bloomfield Hills | Michigan | 48302 | United States | ||
| Jamie Thayer |
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| ID | Title | Description |
|---|---|---|
| FG000 | Erchonia Violet Zerona Z6 | 405nm violet laser light therapy. Erchonia Violet Zerona Z6: 405nm violet diode low level laser device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Erchonia Violet Zerona Z6 | 405nm violet laser light therapy. Erchonia Violet Zerona Z6: 405nm violet diode low level laser device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | inches | 2 weeks |
|
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erchonia Violet Zerona Z6 | 405nm violet laser light therapy. Erchonia Violet Zerona Z6: 405nm violet diode low level laser device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs Manager | Erchonia Corporation | 8882420571 | 501 | tsammons@erchonia.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 22, 2022 | Aug 17, 2023 | Prot_SAP_ICF_000.pdf |
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| Marquette |
| Michigan |
| 49855 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
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