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

NCT ID: NCT04206384

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-02
• Study Completion Date: 2020-05-12

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.

Conditions

Abdominal Subcutaneous Fat

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ultrasound

Intervention Type: DEVICE

Ultimate Contour Body Sculpting Device

Interventions

Ultrasound

Ultimate Contour Body Sculpting Device

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CAO Group, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Just the Right Cruves

Midvale, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

005-00036-8

Identifier Type: -

Identifier Source: org_study_id