SlimShape Device for Abdominal Fat and Circumference Reduction (NCT02999763) | Clinical Trial Compass
CompletedNot Applicable
SlimShape Device for Abdominal Fat and Circumference Reduction
United States70 participantsStarted 2017-01-13
Plain-language summary
Prospective, one-arm, baseline-controlled, clinical study for the evaluation of the SlimShape device for non-invasive abdominal fat and circumference reduction.
Study subjects will undergo SlimShape treatments on the abdominal area.
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
. Signed informed consent to participate in the study.
. Female and male subjects, ≥18 and ≤60 years of age at the time of enrollment
. Fitzpatrick Skin Type I to VI
. BMI interval: 18.5 ≤ BMI ≤ 30 (normal to overweight, but not obese).
. If female, not pregnant, lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence).
. In addition, negative urine pregnancy test as tested before each treatment and at the last visit for women with childbearing potential (e.g. not menopause).
. General good health confirmed by medical history and skin examination of the treated area.
. Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
Exclusion criteria
. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism
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
1
Change in Fat Thickness at Final Follow-up Compared to Baseline
. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease
. Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions
. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
. Having a permanent implant in the treated area, such as metal plates or an injected chemical substance such as silicone
. Having undergone any other surgery in the treated areas within 12 months of treatment or during the study, including liposuction
. Previous body contouring procedures in the treatment area within 12 months
. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing