NCT04206384

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

Completed NA Results posted Last updated 23 August 2021

What this trial tests

NA trial testing Ultrasound in Abdominal Subcutaneous Fat in 52 participants. Completed in 12 May 2020.

Timeline

2 December 2019

Primary endpoint
1 May 2020

12 May 2020

Quick facts

Lead sponsor	CAO Group, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	52
Start date	2 December 2019
Primary completion	1 May 2020
Estimated completion	12 May 2020
Sites	1 location across United States

Drugs / interventions tested

• Ultrasound

Conditions studied

• Abdominal Subcutaneous Fat — all drugs for Abdominal Subcutaneous Fat →

Sponsor

CAO Group, Inc.

Who can join

18 and older, any sex, with Abdominal Subcutaneous Fat. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Waist Circumference Change Primary · 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).

Group	Value	95% CI
Treatment Group	-2.03	± 0.77

Number of Participants With Pain Secondary · 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).

Group	Value	95% CI
Treatment Group	3

Adverse events — posted to ClinicalTrials.gov

Time frame: Collection and follow-up occurred over a space of up to 8 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Group

Serious: 0/52 (0%)

Deaths: 0/52

Other adverse events (7 terms — click to expand)

Reaction	System	Treatment Group
Ringing in the ears	Ear and labyrinth disorders	—
Inflammation / Heat Sensation	Skin and subcutaneous tissue disorders	—
Skin Rash	Skin and subcutaneous tissue disorders	—
Constipation	Gastrointestinal disorders	—
Fatty Urine	Renal and urinary disorders	—
Vertigo	Ear and labyrinth disorders	—
Headache	Nervous system disorders	—

Data from ClinicalTrials.gov NCT04206384 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.