MRI Evaluation of Change in Gluteal Muscles Following the Treatment With HIFEM Device
NCT ID: NCT03815747
Last Updated: 2020-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7 participants
INTERVENTIONAL
2019-01-11
2020-01-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group
Treatment with the investigational device - High- Intensity Focused Electromagnetic (HIFEM) Field Device
High-Intensity Focused Electromagnetic (HIFEM) Field Device
The High-Intensity Focused Electromagnetic (HIFEM) Field device will be applied.
Interventions
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High-Intensity Focused Electromagnetic (HIFEM) Field Device
The High-Intensity Focused Electromagnetic (HIFEM) Field device will be applied.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
Yes
Sponsors
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BTL Industries Ltd.
INDUSTRY
Responsible Party
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Locations
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Art of Skin MD
Solana Beach, California, United States
Countries
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Other Identifiers
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BTL-799-MRI
Identifier Type: -
Identifier Source: org_study_id
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