An interventional study of Ultrasound in Abdominal Subcutaneous Fat, sponsored by CAO Group, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-23.
Sponsored by CAO Group, Inc. · Not applicable, Interventional, and Treatment
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.
CAO Group, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Ultrasound
Ultimate Contour Body Sculpting Device
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).
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.
| Milestone | Treatment Group |
|---|---|
| Started | 52 |
| Completed | 42 |
| Not completed | 10 |
| Withdrew: Withdrawal by subject | 8 |
| Withdrew: Adverse event | 2 |
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).
| Inches | Treatment Group |
|---|---|
| Waist Circumference Change | -2.03 ± 0.77 |
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).
| participants | Treatment Group |
|---|---|
| Number of Participants With Pain | 3 |
Collected over Collection and follow-up occurred over a space of up to 8 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Group | 0/52 (0%) | 0/52 (0%) | 17/52 (32.7%) |
| Event | Treatment Group |
|---|---|
| Ringing in the earsEar and labyrinth disorders | 7/52 |
| Inflammation / Heat SensationSkin and subcutaneous tissue disorders | 5/52 |
| Skin RashSkin and subcutaneous tissue disorders | 1/52 |
| ConstipationGastrointestinal disorders | 1/52 |
| Fatty UrineRenal and urinary disorders | 1/52 |
| VertigoEar and labyrinth disorders | 1/52 |
| HeadacheNervous system disorders | 1/52 |
| Age, Categorical(Participants) | Treatment Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 50 |
| >=65 years | 2 |
| Sex: Female, Male(Participants) | Treatment Group |
|---|---|
| Female | 42 |
| Male | 10 |
| Race (NIH/OMB)(Participants) | Treatment Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 40 |
| More than one race | 5 |
| Unknown or Not Reported | 7 |
| Region of Enrollment(participants) | Treatment Group |
|---|---|
| United States | 52 |
| Waist Circumference(Inches) | Treatment Group |
|---|---|
| Mean | 40.95 ± 5.32 |
| Body Mass Index(kg/m2) | Treatment Group |
|---|---|
| Mean | 29.36 ± 4.23 |
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Plan to share: No
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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CAO Group, Inc.