Fat Reduction Induced by Magnetic Device - Ultrasonographic Evaluation
Status
Conditions
Treatments
Details and patient eligibility
About
The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and four follow-up visits, 1 month, 3, 6 and 12 months after the final treatment.
At the baseline visit photographs of the abdomen will be taken. In addition, adipose/muscle layer thickness will be measured with the ultrasound and the subject's weight will be recorded. In addition, at the last therapy visit, subjects will receive Subject Satisfaction and Therapy Comfort Questionnaires to fill in.
Safety measures will include documentation of adverse events (AE) including subject's experience of pain or discomfort after the procedure. Following each treatment administration and at the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment.
Post-procedure evaluation (follow-up visits) will be conducted 1 month, 3, 6 and 12 months after the final treatment. An ultrasound imaging and weight measure will be conducted. Also, subject's satisfaction will be noted. During the first (1 month), third (6 months) and last (12 months) follow-up visits, photographs of abdomen will be taken.
Sex
Ages
Volunteers
Inclusion criteria
- Adult subjects of both genders with unwanted abdominal fat and expressing interest in treatment
- Age ≥ 22 years
- Voluntarily signed informed consent form
- BMI ≤ 30 kg/m2
Exclusion criteria
- Cardiac pacemakers
- Electronic implants
- Pulmonary insufficiency
- Metal implants
- Drug pumps
- Haemorrhagic conditions
- Anticoagulation therapy
- Heart disorders
- Malignant tumor
- Fever
- Pregnancy
- Breastfeeding
- Following recent surgical procedures when muscle contraction may disrupt the healing process
- Application over menstruating uterus
- Application over areas of the skin which lack normal sensation
- Scars, open lesions and wounds at the treatment area
- Unrepaired abdominal hernia
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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