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The purpose of this study is to test the ability of the lay end user to understand the information contained in the User's Guide; to correctly identify patients who are suitably qualified to receive treatment; and to correctly administer the treatment with the Erchonia ZERONA® Z6 for circumference reduction of the waist, hips and thighs in an over-the-counter setting.
The Erchonia ZERONA® Z6 is a low level laser light therapy device that has been approved by the United States Food and Drug Administration (FDA) for use by licensed medical professionals to help to reduce the circumference of the hips, waist and thighs.
This study is to see if the Erchonia ZERONA® Z6 can be used by lay (non-medical professional) people to treat others to help to reduce the circumference of the hips, waist and thighs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lay End Users | Experimental | Employees of the test sites (that were fitness centers or spas) who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist, hips and thighs of one Treatment Subject. |
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| Treatment Subject Group | Experimental | Treatment subjects received 6 40-minute evenly spaced treatments to the hips, waist and thighs (20 minutes to the front side and 20 minutes to the back side) with the ZERONA Z6 over 2 consecutive weeks. The ZERONA Z6 contains 6 17.25 milliWatts (mW) 635 nanometers (nm) laser diodes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lay End Users | Device | Lay End Users administer 40 minutes of treatment with the ZERONA Z6 to the waist, hips and thighs (20 minutes to the front side and 20 minutes to the back side) of a Treatment Subject, 6 times evenly spaced across two consecutive weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Lay End User Ability to Correctly Choose Suitably Qualified Individuals to Get the ZERONA Z6 Treatments | The number of lay end users who correctly evaluated and selected fully qualified individuals to get the ZERONA Z6 treatment was calculated. | Baseline |
| Lay End User Ability to Correctly Use the ZERONA Z6 and Follow the Treatment Directions. | The number of lay end users who correctly used the ZERONA Z6 to administer treatments by following the treatment administration protocol was calculated | two weeks |
| Average Change in Inches of Total Circumference Measurements for the Treatment Subject Group After 2 Weeks of Treatment With the ZERONA Z6 | Circumference in inches for the waist, hips and both thighs were measured and added together to give a total circumference measurement at baseline and at the end of the 2 weeks of treatment. The change in the total circumference measurement from baseline to the end of treatment was calculated. A decrease (-) in circumference measurement suggests study success and an increase (+) in circumference measurement suggests study failure. A decrease (-) of 3.52 inches (-3.52 inches) or more is positive for study success based on prior published results. | Baseline and 2 weeks |
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Lay End Users
Inclusion Criteria:
Treatment Subjects
Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Zapolsky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lifetime Fitness | Colorado Springs | Colorado | 80920 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lay End Users | Employees of the test sites that were fitness centers or spas who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist, hips and thighs of a Treatment Subject. |
| FG001 | Treatment Subject Group | Subjects who received active treatments with the study device administered by the Lay End Users. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lay End Users | Employees of the test sites (that were fitness centers or spas) who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist, hips and thighs of one Treatment Subject. |
| BG001 |
| 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 | Lay End User Ability to Correctly Choose Suitably Qualified Individuals to Get the ZERONA Z6 Treatments | The number of lay end users who correctly evaluated and selected fully qualified individuals to get the ZERONA Z6 treatment was calculated. | Posted | Number | participants | Baseline |
|
|
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 | ZERONA Z6 | ZERONA Z6 contains 6 17.25 milliWatts (mW) 635 nanometers (nm) light-emitting diodes. 6 40-minute evenly spaced treatments are administered over 2 consecutive weeks. ZERONA Z6: 20 minutes of treatment to the front side of the waist, hips and thighs and 20 minutes of treatment to the back side of the waist, hips and thighs. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elvira Walls, Clinical Consultant | Regulatory Insight, Inc. | 615-712-9743 | elvira@reginsight.com |
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| Treatment Subject Group | Device | Treatment subject received 6 40-minute evenly spaced treatments to the hips, waist and thighs (20 minutes to the front side and 20 minutes to the back side) with the ZERONA Z6 over 2 consecutive weeks. The ZERONA Z6 contains 6 17.25 milliWatts (mW) 635 nanometers (nm) laser diodes. |
|
| Treatment Subject Group |
Treatment subjects received 6 40-minute evenly spaced treatments to the hips, waist and thighs (20 minutes to the front side and 20 minutes to the back side) with the ZERONA Z6 over 2 consecutive weeks. The ZERONA Z6 contains 6 17.25 milliWatts (mW) 635 nanometers (nm) light-emitting diodes. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Body Weight | Mean | Standard Deviation | pounds |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
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| Primary | Lay End User Ability to Correctly Use the ZERONA Z6 and Follow the Treatment Directions. | The number of lay end users who correctly used the ZERONA Z6 to administer treatments by following the treatment administration protocol was calculated | Posted | Number | participants | two weeks |
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| Primary | Average Change in Inches of Total Circumference Measurements for the Treatment Subject Group After 2 Weeks of Treatment With the ZERONA Z6 | Circumference in inches for the waist, hips and both thighs were measured and added together to give a total circumference measurement at baseline and at the end of the 2 weeks of treatment. The change in the total circumference measurement from baseline to the end of treatment was calculated. A decrease (-) in circumference measurement suggests study success and an increase (+) in circumference measurement suggests study failure. A decrease (-) of 3.52 inches (-3.52 inches) or more is positive for study success based on prior published results. | Posted | Mean | Standard Deviation | inches | Baseline and 2 weeks |
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| 0 |
| 22 |
| 0 |
| 22 |
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