Abdominal Subcutaneous Fat
Conditions
Keywords
Ultrasound, Low-Frequency
Brief summary
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.
Detailed description
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.
Interventions
DEVICEUltrasound
Ultimate Contour Body Sculpting Device
Sponsors
CAO Group, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking
Intervention model description
Single Treatment Group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age equal to or above 18 * Body Mass Index ≥ 25.
Exclusion criteria
* Age equal to or below 17. * Body Mass Index \< 25. * Open sores, wounds, or otherwise compromised skin in the treatment area * History of keloid formation, hypertrophic scarring, or abnormal/delayed wound healing. * Known or suspected pregnancy, or active nursing. * General systemic conditions of arteriosclerosis, anemia, aortic aneurysm, or hypertension. * Liver conditions such as hyperlipidemia, hepatitis, liver disease, or abnormal liver function. * Diabetes or blood-glucose sensitivity * Any prior invasive cosmetic surgery to the waist or abdominal area, such as liposuction. * Hernias or diastasis recti within the treatment area. * Concurrent, or within the last 6 months, participation in any clinical trial for another device or drug. * Existing bacterial or viral infections (influenza, rhinovirus, hepatitis, pneumonia, tuberculosis, and the like) * Presence of acne vulgaris, herpes zoster, psoriasis vulgaris, or similar skin conditions in the treatment area. * Any type of cosmetic treatment to the target area within the last 6 months. * Implanted active medical device anywhere in the subject, or metallic or polymeric implants in the vicinity of the treatment area. * Currently undergoing, or recently underwent, chemotherapy or radiation treatment. * Per the investigator's discretion, any physical or mental condition which may compromise the patient's safety or welfare. * Failure to complete the study as outlined.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Waist Circumference Change | 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). | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Pain | 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. | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Treatment Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants |
| Body Mass Index | 29.36 kg/m2 STANDARD_DEVIATION 4.23 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Region of Enrollment United States | 52 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 10 Participants |
| Waist Circumference | 40.95 Inches STANDARD_DEVIATION 5.32 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 52 |
| other Total, other adverse events | 17 / 52 |
| serious Total, serious adverse events | 0 / 52 |
Outcome results
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).
Time frame: 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).
Population: Participants who completed treatment process and follow-up visits as described.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Waist Circumference Change | -2.03 Inches | Standard Deviation 0.77 |
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).
Time frame: 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.
Population: Assessment of participant during or after any treatment application.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Group | Number of Participants With Pain | 3 participants |