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CompletedNCT03758690Updated May 27, 2020

High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth

An interventional study of High-Intensity Focused Electromagnetic (HIFEM) Field Device in Muscle Tone Increased, sponsored by BTL Industries Ltd.. Completed at 2 sites in United States. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-27.

Sponsored by BTL Industries Ltd. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Aug 2019, 7 years 2 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
21 Years and older
Sex
Female
01

Study summary

Evaluation of use of the High-Intensity Focused Electromagnetic (HIFEM) Field Device in women after childbirth.

02

Conditions studied

  • Muscle Tone Increased

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03

In context

Muscle Hypertonia

45 studies on the registry are indexed under Muscle Hypertonia; 6 are open to participants now.

This study's enrollment of 10 is below the median of 34 across 24 interventional studies indexed under Muscle Hypertonia.

Browse Muscle Hypertonia studies →

Lead sponsor

BTL Industries Ltd. is the lead sponsor of 77 studies on the registry; 5 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse BTL Industries Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Non-breastfeeding women 3-36 months after childbirth
  • 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

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
  • 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
  • Patients after Cesarean section delivery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Treatment Group

    Treatment with the investigational device - High-Intensity Focused Electromagnetic (HIFEM) Field Device

    Device: High-Intensity Focused Electromagnetic (HIFEM) Field Device

Interventions

  • DeviceHigh-Intensity Focused Electromagnetic (HIFEM) Field Device

    The High-Intensity Focused Electromagnetic (HIFEM) Field device will be applied.

06

What researchers measure

Primary outcomes

  1. Effectiveness of the device for abdominal toning according to MRI images

    Evaluation of MRI images before and after the therapy procedure.

    Time frame: 7 months

  2. Effectiveness of the device for abdominal toning according to waist circumference measurements

    Evaluation of waist circumference measurements (in centimeters).

    Time frame: 7 months

Secondary outcomes

  1. Subject's satisfaction with study treatment: Questionnaire

    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

  2. Determination of 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

    Time frame: 7 months

07

Study locations

2 sites
  • Skin Care Physicians of Georgia
    Macon, Georgia 31217, United States
  • Chicago Cosmetic Surgery and Dermatology
    Chicago, Illinois 60654, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2018 to primary completion in Aug 2019, 9 months.

Of 13 interventional studies with no phase under Muscle Hypertonia, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 34. This study's 9 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 26, 2018
First posted
Nov 29, 2018
StartActual
Oct 25, 2018
Primary completionActual
Aug 13, 2019
CompletionActual
Jan 2, 2020
Last update
May 27, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03758690
Lead sponsor
BTL Industries Ltd.
Responsible party
Sponsor
First posted
Nov 29, 2018
Start date
Oct 25, 2018
Primary completion
Aug 13, 2019
Completion
Jan 2, 2020
Last update
May 27, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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