Changes in Abdominal Tissues Induced by Magnetic Device - MRI Evaluation

Withdrawn before enrolling · Not applicable

Conditions studied: Fat Burn

In brief

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.

Key facts

Study ID

NCT03545633

Run by

BTL Industries Ltd.

People needed

0

Starts

2017-12-15

Expected to finish

2019-06-15

Last updated by the study team

2020-09-14

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Plastic Surgery Excellence — Beverly Hills, California, United States
• Paula Fines Center — Sofia, Bulgaria

Full record on ClinicalTrials.gov

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