Subcutaneous Contouring Using High Intensity Focused Ultrasound

An Evaluation of the Treatment of Adipose Tissue Using a Focused Ultrasound Device in Subjects With Fitzpatrick IV-VI Skin Types

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01104272

Enrollment

Registered

2010-04-15

Start date

2010-04-30

Completion date

2011-01-31

Last updated

2011-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Sculpting

Keywords

Ultrasound Treatment of Subcutaneous Adipose Tissue

Brief summary

The device delivers High Intensity Focused Ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to body sculpting, such as a reduction in waist circumference.

Interventions

DEVICELipoSonix (Ultrasound treatment of Subcutaneous Adipose Tissue)

Study of Adipose Tissue Treatment Using Focused Ultrasound

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

All of the following inclusion criteria must be met at the time of screening before the subject is enrolled into the study: 1. Male or female subjects, 18 to 65 years of age 2. Body Mass Index ≤30 3. Thickness of subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.5 cm 4. Subjects must agree to not alter their normal and regular diet or exercise routines during the course of the study. 5. Subjects must be of African descent AND have Fitzpatrick skin types IV, V, or VI.

Exclusion criteria

A subject is ineligible to participate in this study if they meet any of the following

Design outcomes

Primary

Measure	Time frame
Change from baseline in waist circumference	12 weeks

Secondary

Measure	Time frame
The change from Baseline in waist circumference measured after treatment, for the average of the two waist circumference measurements at the iliac crest as well as for each of the individual measurements.	4 weeks
Patient satisfaction as recorded on the Subject Satisfaction Survey after treatment.	1 week
Visual Analog Scale (VAS) diary to record post treatment discomfort.	1 week
Improvement as determined by a Global Aesthetic Improvement Scale (GAIS) score of 'improved' or 'much improved' at each post-baseline visit, as assessed by the Investigator.	1 week

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026