MRI Evaluation of Change in Gluteal Muscles Following the Treatment With HIFEM Device
Primary Purpose
Muscle Tone Increased
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-Intensity Focused Electromagnetic (HIFEM) Field Device
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Tone Increased
Eligibility Criteria
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
Sites / Locations
- Art of Skin MD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
Treatment with the investigational device - High- Intensity Focused Electromagnetic (HIFEM) Field Device
Outcomes
Primary Outcome Measures
Effectiveness of the device for toning of buttocks according to MRI images
Evaluation of change in MRI images before and after the therapy procedure.
Secondary Outcome Measures
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03815747
Brief Title
MRI Evaluation of Change in Gluteal Muscles Following the Treatment With HIFEM Device
Official Title
MRI Evaluation of Change in Gluteal Muscles Following the Treatment With HIFEM Device
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 11, 2019 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
January 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BTL Industries Ltd.
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Tone Increased
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Treatment with the investigational device - High- Intensity Focused Electromagnetic (HIFEM) Field Device
Intervention Type
Device
Intervention Name(s)
High-Intensity Focused Electromagnetic (HIFEM) Field Device
Intervention Description
The High-Intensity Focused Electromagnetic (HIFEM) Field device will be applied.
Primary Outcome Measure Information:
Title
Effectiveness of the device for toning of buttocks according to MRI images
Description
Evaluation of change in MRI images before and after the therapy procedure.
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Subject's satisfaction with study treatment
Description
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.
Time Frame
7 months
Title
Side effects and adverse events (AE) associated with the study device
Description
The occurrence of side effects and adverse events will be followed throughout the whole study
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Art of Skin MD
City
Solana Beach
State/Province
California
ZIP/Postal Code
92075
Country
United States
12. IPD Sharing Statement
Learn more about this trial
MRI Evaluation of Change in Gluteal Muscles Following the Treatment With HIFEM Device
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