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This study evaluates the effectiveness and safety of externally applied lower frequency ultrasound to the waist/abdominal region of adults to achieve a reduction of fat cells/tissues below the skin, evidenced by a reduction in patient waist circumference.
This study is to evaluate principally the effectiveness, and secondarily the safety, of external application of lower frequency ultrasound to the waist/abdominal region of adults to achieve a reduction of adipose cells/tissues in the subcutaneous region. The application of higher frequency (200kHz to 3MHz) ultrasound for this purpose has previously been demonstrated and such devices have received clearance for treatment in the United States. The question remains whether application of ultrasound at a lower frequency (35kHz to 45kHz) can achieve comparable results without introducing any new or elevated risks to the patient. This study will apply 3 treatments of the ultrasound energy and evaluate the change in patient's waist circumference, which would be evidence of reducing sub-cutaneous adipose cells/tissues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Each patient shall receive a total of 3 treatments. Each treatment shall consist of applying the ultrasound device for 30 minutes to the skin surface, working the device methodically over the abdominal area. The device shall be set at the maximum emission level, have an intensity of approximately 1.0 watt/cm^2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Device | Ultimate Contour Body Sculpting Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Waist Circumference Change | Change in measurable circumference of the patient's abdominal area from Baseline to immediately after the 4-week follow-up assessment (approximately 6 weeks from Baseline). | The difference between the circumference measurement immediately prior to the first treatment (Baseline) to immediately after the 4-week follow-up assessment (approximately 6 weeks from Baseline). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Pain | Incidence of pain during each application of the device and/or immediately following each application of the device (up to 15 minutes after use of the device ceased). | Assessed during and immediately after (up to 15 minutes after use ceased) each application of the device, and at 1 week, 4 weeks, and 12 weeks post-treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Just the Right Cruves | Midvale | Utah | 84047 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | Each patient shall receive a total of 3 treatments. Each treatment shall consist of applying the ultrasound device for 30 minutes to the skin surface, working the device methodically over the abdominal area. The device shall be set at the maximum emission level, have an intensity of approximately 1.0 watt/cm^2. Ultrasound: Ultimate Contour Body Sculpting Device |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | Each patient shall receive a total of 3 treatments. Each treatment shall consist of applying the ultrasound device for 30 minutes to the skin surface, working the device methodically over the abdominal area. The device shall be set at the maximum emission level, have an intensity of approximately 1.0 watt/cm^2. Ultrasound: Ultimate Contour Body Sculpting Device |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Waist Circumference Change | Change in measurable circumference of the patient's abdominal area from Baseline to immediately after the 4-week follow-up assessment (approximately 6 weeks from Baseline). | Participants who completed treatment process and follow-up visits as described. | Posted | Mean | Standard Deviation | Inches | The difference between the circumference measurement immediately prior to the first treatment (Baseline) to immediately after the 4-week follow-up assessment (approximately 6 weeks from Baseline). |
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Collection and follow-up occurred over a space of up to 8 weeks.
No difference in definition. Event collection consisted of enquiring of the participant any observations following application of the device. Participants were to keep a study diary and document any observations. Investigator reviewed study diaries and identified any comments that constitute an adverse event.
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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 | Treatment Group | Each patient shall receive a total of 3 treatments. Each treatment shall consist of applying the ultrasound device for 30 minutes to the skin surface, working the device methodically over the abdominal area. The device shall be set at the maximum emission level, have an intensity of approximately 1.0 watt/cm^2. Ultrasound: Ultimate Contour Body Sculpting Device |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ringing in the ears | Ear and labyrinth disorders | Non-systematic Assessment | During application of the device, some participants reported hearing a ringing or buzzing in their ears, although the device or applicator handpiece were not generating an externally audible noise. |
Due to the coronavirus (COVID-19) pandemic, the planned 12-week follow-up was conducted virtually. This prevented capture of the primary measurement at this timepoint.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Quality & Regulatory | CAO Group | 801-256-9282 | info@caogroup.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2019 | Dec 17, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 30, 2019 | Dec 17, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Single Treatment Group
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No masking
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| Participants |
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| 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 |
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| Waist Circumference | Mean | Standard Deviation | Inches |
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| Body Mass Index | Mean | Standard Deviation | kg/m2 |
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| Secondary | Number of Participants With Pain | Incidence of pain during each application of the device and/or immediately following each application of the device (up to 15 minutes after use of the device ceased). | Assessment of participant during or after any treatment application. | Posted | Number | participants | Assessed during and immediately after (up to 15 minutes after use ceased) each application of the device, and at 1 week, 4 weeks, and 12 weeks post-treatment. |
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| 0 |
| 52 |
| 0 |
| 52 |
| 17 |
| 52 |
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| Skin Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Participant developed a rash a day after a treatment. |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment | Participant developed constipation 2 days after a treatment session. |
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| Inflammation / Heat Sensation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Participant indicated feeling heat at the application site and/or presented with redness or inflammation of the treatment site. |
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| Fatty Urine | Renal and urinary disorders | Non-systematic Assessment | Participant described seeing fatty or cloudy urine |
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| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment | Participant complained of vertigo when getting up from the treatment table following use of the device. |
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| Headache | Nervous system disorders | Non-systematic Assessment | Participant described having a mild headache, the evening after a treatment. |
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