MRI Evaluation of Change in Gluteal Muscles Following the Treatment With HIFEM Device
1 other identifier
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 11, 2019
CompletedFirst Submitted
Initial submission to the registry
January 22, 2019
CompletedFirst Posted
Study publicly available on registry
January 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2020
CompletedMay 20, 2020
May 1, 2020
7 months
January 22, 2019
May 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Subject's satisfaction with study treatment
7 months
Side effects and adverse events (AE) associated with the study device
7 months
Study Arms (1)
Treatment Group
EXPERIMENTALTreatment with the investigational device - High- Intensity Focused Electromagnetic (HIFEM) Field Device
Interventions
The High-Intensity Focused Electromagnetic (HIFEM) Field device will be applied.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Art of Skin MD
Solana Beach, California, 92075, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
January 22, 2019
First Posted
January 24, 2019
Study Start
January 11, 2019
Primary Completion
July 30, 2019
Study Completion
January 27, 2020
Last Updated
May 20, 2020
Record last verified: 2020-05