CompletedNot Applicable

Subcutaneous Contouring Using High Intensity Focused Ultrasound

Canada36 participantsStarted 2010-04

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Male or female subjects, 18 to 65 years of age
✓. Body Mass Index ≤30
✓. Thickness of subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.5 cm
✓. Subjects must agree to not alter their normal and regular diet or exercise routines during the course of the study.
✓. Subjects must be of African descent AND have Fitzpatrick skin types IV, V, or VI.

Exclusion criteria

✕. Female subject who is pregnant (i.e., has a positive urine pregnancy test), is suspected to be pregnant, or is lactating or becomes pregnant during the course of the study. (NOTE: Females of childbearing potential must have a negative urine pregnancy test prior to enrollment in the study.)
✕. Subjects diagnosed with coagulation disorders or are receiving anticoagulant therapy or medications or dietary supplements which impede coagulation or platelet aggregation.
✕. Subject has diabetes or cardiovascular disease.
✕. Subject has had any aesthetic procedure to the region to be treated.
✕. Subject has systemic skin disease or skin disease in the areas to be treated.
✕. Subject has any abnormality of the skin or soft tissues of the abdominal wall in the areas to be treated.
✕. Subject has had previous open or laparoscopic surgery in the anticipated treatment area.
✕. Subjects is on prescription or over the counter weight reduction medication or programs, or had weight reduction procedures (e.g.: gastric bypass, Lap-Band, etc.)

What they're measuring

Change from baseline in waist circumference

Timeframe: 12 weeks

Trial details

NCT IDNCT01104272

SponsorMedicis Technologies Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-01

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