Status:
COMPLETED
HIFEM for Arms, Lower Limbs, and Oblique Muscles
Lead Sponsor:
BTL Industries Ltd.
Conditions:
Muscle Tone Increased
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Evaluation of HIFEM treatments for strengthening and toning of arms, lower limbs and oblique muscles.
Detailed 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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2020
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04426526
Start Date
May 8 2019
End Date
December 8 2020
Last Update
January 13 2021
Active Locations (2)
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1
Plastic Surgical Associates
Fort Collins, Colorado, United States, 80525
2
Juva Skin & Laser Center
New York, New York, United States, 11377