Changes in Abdominal Tissues Induced by Magnetic Device - MRI Evaluation

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Fat Burn
• Intervention / Treatment: Device: Treatment with High Intensity Focused ElectroMagnetic system.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1632
    • Paula Fines Center
• United States
  • California
    • Beverly Hills, California, United States, 90212
      • Plastic Surgery Excellence

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; Treatment with the investigational device - High Intensity Focused ElectroMagnetic System	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2017
• Primary Completion (Anticipated): May 15, 2019
• Study Completion (Anticipated): June 15, 2019

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Actual): September 14, 2020
• Last Update Submitted That Met QC Criteria: September 10, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Abdominal tissues
• Other Study ID Numbers: BTL-Abdomen_002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No