Subcutaneous Contouring Using High Intensity Focused Ultrasound (NCT01104272) | Clinical Trial Compass
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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.)