CompletedNot Applicable

Ultrashape System in Combination With VelaShape II Device for Circumferential Reduction

Canada21 participantsStarted 2012-10

Plain-language summary

The purpose of this study is to compare the clinical performance of the Ultrashape system with VelaShape II device for reduction of the waist.

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

. Fat thickness of at least 1.5 cm in the anterior abdominal and flanks prior to initial treatment (measurement by caliper)
. For women of child-bearing potential: negative pregnancy test in the 24 hour period prior to enrollment and 24 hour period prior to each treatment or FU visit (measured in urine)
. General good health confirmed by medical history and skin examination of the treated area
. Written informed consent to participate in the study
. Ability to comply with the requirements of the study
. BMI≤ 30

Exclusion criteria

. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism
. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease or malignancy
. Previous liposuction in the treatment areas
. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing

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.

What they're measuring

Difference in circumference reduction between baseline and follow-up visits

Timeframe: Base line, 2 and 12 weeks post last treatment

Trial details

NCT IDNCT02154113

SponsorSyneron Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-08

View on ClinicalTrials.gov More Abdominal Fat trials