Abdomen – Fat Reduction and Muscle Toning

Overview

This study will evaluate the clinical efficacy and safety of a simultaneous treatment by repetitive pulse magnetic stimulation and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. 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 three (3) treatment visits and two to three follow-up visits. All of the study subjects will receive the treatment with the subject device.

Full Title of Study: “Abdominal Treatment With Simultaneous Application of Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) and Radiofrequency”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2021

Detailed Description

This study will evaluate the clinical efficacy and safety of a simultaneous treatment by repetitive pulse magnetic stimulation and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. 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 three (3) treatment visits and two to three follow-up visits. All of the study subjects will receive the treatment with the subject device.

At the baseline visit MRI will be performed, subject's weight and waist circumference will be recorded. Photos of the treated area will be taken.

The treatment administration phase will consist of three (3) treatments, delivered once a week. The applicator will be applied over umbilicus and visible muscle contractions along with heating of the subcutaneous fat will be induced by the device.

At the last therapy visit, the subject's weight and waist circumference will be recorded, and photos of the treated area will be taken. In addition, subjects will receive Subject Satisfaction Questionnaire to fill in.

Safety measures will include documentation of adverse events (AE) including subject's experience of pain or discomfort after each procedure. Following each treatment administration and at all of the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment.

During the post-procedure visits (at 1-month and 3-month follow-up visits), the subjects will undergo MRI scanning. Also, subject's satisfaction will be noted and weight with waist circumference will be recorded. Photographs of the treated area will be taken. There will be an option of a 6-months follow-up visit, according to subject's availability.

Interventions

  • Device: rPMS+RF
    • The treatment administration phase will consist of three (3) treatments, delivered once a week. The applicator of the device will be applied over umbilicus and visible muscle contractions along with heating of the subcutaneous fat will be induced by the device.

Arms, Groups and Cohorts

  • Experimental: Abdominal Toning and Reduction of Subcutaneous Fat
    • simultaneous treatment by repetitive pulse magnetic stimulation and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat

Clinical Trial Outcome Measures

Primary Measures

  • Evaluation of change in adipose and muscular layer thickness between pre-treatment and post-treatment based on MRI scans
    • Time Frame: 4 months
    • MRI will be conducted at the baseline visit and all follow-up visits. The imaging will be conducted at the same surface area each time. Hospital-grade MRI device will be used to scan abdominal area of each subject. The MRI scan without any contrast agent will be performed, with the scanned body segment determined by vertebrae T12 and S1. Lateral cuts from 5 cm below the umbilicus and 5 cm above the umbilicus will be evaluated for the thickness of muscle and subcutaneous adipose tissue.
  • Evaluation of change in adipose layer thickness between pre-treatment and post-treatment based on waist circumference measurements
    • Time Frame: 4 months
    • Waist circumference measure will be conducted at the baseline visit, after last treatment and during follow-up visits. The waist circumference measure will be made at the top of the subject’s iliac crest, with the tape held snugly, but not constricting, and at a level parallel to the floor. For the measurement, a stretch-resistant tape will be used. During the measuring, subject will stand with arms at the side, feet positioned close together, and weight evenly distributed across the feet. The subject will be instructed to relax and take a few deep, natural breaths before the actual measurement is made. The subjects will be measured in underwear only, after voiding the bladder.

Secondary Measures

  • Evaluation of subject’s satisfaction with the treatment using the Subject Satisfaction Questionnaire
    • Time Frame: 7 months
    • The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant’s satisfaction with the therapy outcome with answer “Strongly agree” being the most positive outcome and “Strongly disagree” the most negative. Subject satisfaction will be assessed after the last therapy visit and during the follow-up visits.
  • Safety of the device measured via the occurrence of adverse events or lack thereof
    • Time Frame: 7 months
    • The occurrence of adverse events will be followed throughout the whole study.

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥ 21 years
  • Voluntarily signed informed consent form
  • BMI ≤ 35 kg/m2
  • Women of child-bearing potential are required to use birth control measures during the whole duration of the study
  • Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
  • Subjects willing and able to maintain her regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation

Exclusion Criteria

  • Electronic implants (such as cardiac pacemakers, defibrillators and neurostimulators)
  • Metal implants
  • Drug pumps
  • Malignant tumour
  • Pulmonary insufficiency
  • Injured or otherwise impaired muscles
  • Cardiovascular diseases
  • Disturbance of temperature or pain perception
  • Hemorrhagic conditions
  • Septic conditions and empyema
  • Acute inflammations
  • Systemic or local infection such as osteomyelitis and tuberculosis
  • Contagious skin disease
  • Elevated body temperature
  • Pregnancy, postpartum period, nursing, and menstruation
  • Intrauterine device (IUD)
  • Swollen or neoplastic tissues, space occupying lesions or skin eruptions in the treatment area
  • Basedow's disease

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • BTL Industries Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

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