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

Muscle Tone Increased Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03815747
• Other study ID #: BTL-799-MRI
• Status: Completed
• Phase: N/A
• Start date: January 11, 2019
• Est. completion date: January 27, 2020

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 27, 2020
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Hypertonia
• Muscle Tone Increased

Intervention

Device:
• High-Intensity Focused Electromagnetic (HIFEM) Field Device
The High-Intensity Focused Electromagnetic (HIFEM) Field device will be applied.

Locations

Country	Name	City	State
United States	Art of Skin MD	Solana Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
BTL Industries Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of the device for toning of buttocks according to MRI images	Evaluation of change in MRI images before and after the therapy procedure.	7 months
Secondary	Subject's satisfaction with study treatment	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.	7 months
Secondary	Side effects and adverse events (AE) associated with the study device	The occurrence of side effects and adverse events will be followed throughout the whole study	7 months