HIFEM for Arms Lower Limbs and Oblique Muscles

  • STATUS
    Recruiting
  • participants needed
    80
  • sponsor
    BTL Industries Ltd.
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Updated on 16 February 2024
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Summary

Evaluation of HIFEM treatments for strengthening and toning of arms, lower limbs and oblique muscles.

Description

This study will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of arm, lower limb and oblique muscles. The study is a prospective multi-center open-label four-arm study.

Details
Condition Hypertonia
Age 21years - 100years
Treatment BTL 799-2
Clinical Study IdentifierNCT04426526
SponsorBTL Industries Ltd.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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 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
Application in the head area
Application in the heart area
Malignant tumor
Injured or otherwise impaired muscles
Fever
Pregnancy
Sensitivity or allergy to latex
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
Patients after Cesarean section delivery
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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