Clinical trial NCT03545633: Changes in Abdominal Tissues Induced by Magnetic Device - MRI Evaluation
Official title: Safety and Efficacy of Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) for Fat Disruption of the Abdomen
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Fat Burn
Keywords: Abdominal tissues
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2018-06-04
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Effectiveness of the device assessed through photography evaluation
timeFrame: 13 months
measure: Effectiveness of the device assessed through change in adipose/muscle layer thickness
timeFrame: 13 months
measure: Subject's satisfaction
timeFrame: 13 months
Secondary outcomes:
measure: Safety of the device for non-invasive fat disruption
timeFrame: 13 months
measure: Therapy comfort
timeFrame: 3 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Plastic Surgery Excellence
state: California
city: Sofia
country: Bulgaria
facility: Paula Fines Center
Study officials:
References: