Low-Frequency, High-Intensity Ultrasound for Waist Circumference Reduction

• Sponsor: CAO Group, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04206384
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.3
• Patients Per Site Per Month: 9.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Subcutaneous Fat	Device: Ultrasound	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single Treatment GroupSingle Treatment Group
• Masking: None (Open Label)
• Masking Description: No masking
• Primary Purpose: Treatment
• Official Title: Efficacy of Low-Frequency, High-Intensity Ultrasound for Reduction in Subdermal Adipose Layers
• Actual Study Start Date: Dec 2, 2019
• Actual Primary Completion Date: May 1, 2020
• Actual Study Completion Date: May 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Ultrasound; Ultimate Contour Body Sculpting Device

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Just the Right Cruves	Midvale	Utah	United States	84047

Sponsors and Collaborators

• CAO Group, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 10, 2019
• Informed Consent Form - Oct 30, 2019

More Information

Publications

None provided.

• Responsible Party: CAO Group, Inc.
• ClinicalTrials.gov Identifier: NCT04206384
• Other Study ID Numbers: 005-00036-8
• First Posted: Dec 20, 2019
• Last Update Posted: Aug 23, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by CAO Group, Inc.: Ultrasound; Low-Frequency

Study Results

Participant Flow

Arm/Group Title	Treatment Group
Arm/Group Description	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
Period Title: Overall Study
STARTED	52
COMPLETED	42
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Treatment Group
Arm/Group Description	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
Overall Participants	52
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	50 96.2%
>=65 years	2 3.8%
Sex: Female, Male (Count of Participants)
Female	42 80.8%
Male	10 19.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	40 76.9%
More than one race	5 9.6%
Unknown or Not Reported	7 13.5%
Region of Enrollment (participants) [Number]
United States	52 100%
Waist Circumference (Inches) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Inches]	40.95 (5.32)
Body Mass Index (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	29.36 (4.23)

Outcome Measures

1. Primary Outcome

Title	Waist Circumference Change
Description	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).

Outcome Measure Data

Analysis Population Description

Participants who completed treatment process and follow-up visits as described.

Arm/Group Title	Treatment Group
Arm/Group Description	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
Measure Participants	42
Mean (Standard Deviation) [Inches]	-2.03 (0.77)

2. Secondary Outcome

Title	Number of Participants With Pain
Description	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.

Outcome Measure Data

Analysis Population Description

Assessment of participant during or after any treatment application.

Arm/Group Title	Treatment Group
Arm/Group Description	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
Measure Participants	52
Number [participants]	3 5.8%

Adverse Events

Time Frame	Collection and follow-up occurred over a space of up to 8 weeks.
Adverse Event Reporting Description	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.
Arm/Group Title	Treatment Group
Arm/Group Description	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
All Cause Mortality
	Treatment Group
	Affected / at Risk (%)	# Events
Total	0/52 (0%)
Serious Adverse Events
	Treatment Group
	Affected / at Risk (%)	# Events
Total	0/52 (0%)
Other (Not Including Serious) Adverse Events
	Treatment Group
	Affected / at Risk (%)	# Events
Total	17/52 (32.7%)
Ear and labyrinth disorders
Ringing in the ears	7/52 (13.5%)	7
Vertigo	1/52 (1.9%)	1
Gastrointestinal disorders
Constipation	1/52 (1.9%)	1
Nervous system disorders
Headache	1/52 (1.9%)	1
Renal and urinary disorders
Fatty Urine	1/52 (1.9%)	1
Skin and subcutaneous tissue disorders
Skin Rash	1/52 (1.9%)	1
Inflammation / Heat Sensation	5/52 (9.6%)	5

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.