N/A
N=52
Low-Frequency, High-Intensity Ultrasound for Waist Circumference Reduction
Abdominal Subcutaneous Fat
Bottom Line
View on ClinicalTrials.gov: NCT04206384 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Waist Circumference Change — -2.03 Inches
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ultrasound (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CAO Group, Inc.
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Waist Circumference Change |
-2.03 | — |
| SECONDARY Number of Participants With Pain |
3 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04206384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.