MRI Evaluation of Change in Gluteal Muscles Following the Treatment With HIFEM Device

Not Applicable

Completed

• Conditions: Muscle Tone Increased
• Interventions: Device: High-Intensity Focused Electromagnetic (HIFEM) Field Device

• Registration Number: NCT03815747
• Lead Sponsor: BTL Industries Ltd.

Brief Summary

This study will use magnetic resonance imaging (MRI) to evaluate changes in gluteal muscle following the treatment with HIFEM stimulation for aesthetic improvement of buttocks.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-11
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-23
• Study First Posted: 2019-01-24
• Primary Completion: 2019-07-30
• Study Completion: 2020-01-27
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Age ≥ 21 years
• Voluntarily signed informed consent form
• BMI ≤ 30 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 his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation

Exclusion Criteria

• Cardiac pacemakers
• Implanted defibrillators, implanted neurostimulators
• Electronic implants
• Pulmonary insufficiency
• Metal implants
• Drug pumps
• Malignant tumor
• Fever
• Pregnancy
• Breastfeeding
• Following recent surgical procedures when muscle contraction may disrupt the healing process
• Application over areas of the skin which lack normal sensation
• Scars, open lesions and wounds at the treatment area
• Unrepaired abdominal hernia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	High-Intensity Focused Electromagnetic (HIFEM) Field Device	Treatment with the investigational device - High- Intensity Focused Electromagnetic (HIFEM) Field Device

Primary Outcome Measures

Name	Time	Method
Effectiveness of the device for toning of buttocks according to MRI images	7 months	Evaluation of change in MRI images before and after the therapy procedure.

Secondary Outcome Measures

Name	Time	Method
Subject's satisfaction with study treatment	7 months	Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire. The 7-point Likert scale Subject Satisfaction Questionnaire will be used for an analysis of the subject's opinion of the therapy results.
Side effects and adverse events (AE) associated with the study device	7 months	The occurrence of side effects and adverse events will be followed throughout the whole study

Trial Locations

Locations (1)

Art of Skin MD; 🇺🇸 Solana Beach, California, United States