Changes in Abdominal Tissues Induced by Magnetic Device - MRI Evaluation

Study Overview
=================
Brief Summary
-----------------
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 three follow-up visits, 2 months, 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 magnetic resonance imaging and the subject's weight will be recorded. 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. In addition, at the last therapy visit, subjects will receive Subject Satisfaction and Therapy Comfort Questionnaires to fill in. Post-procedure evaluation (follow-up visits) will be conducted 2, 6 and 12 months after the final treatment. During those visits, magnetic resonance imaging, photographing and weight measure will be conducted. Subject Satisfaction Questionnaire will be given at every follow-up visit.

Official Title
-----------------
Safety and Efficacy of Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) for Fat Disruption of the Abdomen

Conditions
-----------------
Fat Burn

Intervention / Treatment
-----------------
* Device: Treatment with High Intensity Focused ElectroMagnetic system.


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Treatment with the investigational device - High Intensity Focused ElectroMagnetic System | Device: Treatment with High Intensity Focused ElectroMagnetic system.<br>* The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the abdomen area. Visible contractions will be induced by the device.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the device assessed through photography evaluation | Photography evaluations with correct identification of pre-treatment images compared to post-treatment images. | 13 months | 
| Effectiveness of the device assessed through change in adipose/muscle layer thickness | Change in adipose/muscle layer thickness between pre-treatment and post-treatment based on magnetic resonance imaging measurements. | 13 months | 
| Subject's satisfaction | The 5-point Likert scale Subject Satisfaction Questionnaire will be used for an analysis of the subject's opinion of the therapy results. Subjects will be evaluating agreement with three different statements (concerning satisfaction with therapy results and appearance of abdominal area after therapy) by choosing an answer on a scale between 1 (Strongly disagree) and 5 (Strongly agree). Minimally 80% of the treated subjects should report the agreement with all three statements given in the questionnaire (answers Agree and Strongly agree) in order to claim subject's satisfaction with the therapy outcome. | 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the device for non-invasive fat disruption | The secondary objective of the study is to determine side effects and adverse events (AE) associated with the treatment of the abdominal area. The occurrence of adverse events will be followed throughout the whole study. | 13 months | 
| Therapy comfort | Therapy comfort will be noted at the last therapy visit. Subjects will be asked to evaluate the agreement with the statement concerning the conformity of the study treatment. Subjects will be evaluating the agreement by choosing an answer on a scale between 1 (Strongly disagree) and 5 (Strongly agree). Based on a given answers, the therapy comfort will be calculated. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominal tissues