UltraShape Power in Combination With U-sculpt-n Transducer (NCT02956720) | Clinical Trial Compass
UnknownNot Applicable
UltraShape Power in Combination With U-sculpt-n Transducer
Israel24 participantsStarted 2017-01
Plain-language summary
Prospective, open label, self - controlled, single arm, clinical study to assess the performance of the UltraShape Power using the U-Sculpt-N on outer thigh and/or flank for circumference reduction versus self-control.
Who can participate
Age range
18 Years – 60 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
. Subject ≥18 and ≤60 years of age at the time of enrollment
. Fat thickness of at least 1.5 cm in the outer thigh and/or flank (measured by calibrated caliper)
. For women of child-bearing potential: negative urine pregnancy test
. General good health confirmed by medical history and skin examination of the treated area
. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
Exclusion criteria
. History of un-balanced hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator
. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease
. Having a permanent implant in the treated area, such as metal plates, or an injected chemical substance such as silicone
. Previous liposuction in the treatment areas within 12 months
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.