Abdomen - Fat Reduction and Muscle Toning

NCT04587804 | Completed FDA Device

• 1 other identifier: BTL-703_100
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Fat Burn

Outcome Measures

Primary Outcomes (2)

• Evaluation of change in adipose and muscular layer thickness between pre-treatment and post-treatment based on MRI scans

  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.

  4 months

• Evaluation of change in adipose layer thickness between pre-treatment and post-treatment based on waist circumference measurements

  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.

  4 months

Secondary Outcomes (2)

• Evaluation of subject's satisfaction with the treatment using the Subject Satisfaction Questionnaire

  7 months

• Safety of the device measured via the occurrence of adverse events or lack thereof

  7 months

Study Arms (1)

Abdominal Toning and Reduction of Subcutaneous Fat

EXPERIMENTAL

simultaneous treatment by repetitive pulse magnetic stimulation and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat

Device: rPMS+RF

Interventions

rPMS+RF DEVICE

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.

Abdominal Toning and Reduction of Subcutaneous Fat

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (2)

Skin Care Physicians of Georgia

Macon, Georgia, 31217, United States

Location

Chicago Cosmetic Surgery and Dermatology

Chicago, Illinois, 60654, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 14, 2020
• Study Start: June 17, 2019
• Primary Completion: June 9, 2020
• Study Completion: March 15, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

US (2)