Changes in Abdominal Tissues Induced by Magnetic Device - MRI Evaluation

Fat Burn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03545633
• Other study ID #: BTL-Abdomen_002
• Status: Withdrawn
• Phase: N/A
• Start date: December 15, 2017
• Est. completion date: June 15, 2019

Study information

• Verified date: September 2020
• Source: BTL Industries Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fat Burn

Intervention

Device:
• Treatment with High Intensity Focused ElectroMagnetic system.
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.

Locations

Country	Name	City	State
Bulgaria	Paula Fines Center	Sofia
United States	Plastic Surgery Excellence	Beverly Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
BTL Industries Ltd.

Countries where clinical trial is conducted

United States,  Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of the device assessed through photography evaluation	Photography evaluations with correct identification of pre-treatment images compared to post-treatment images.	13 months
Primary	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
Primary	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	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
Secondary	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