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

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BTL

Status

Completed

Conditions

Muscle Tone Increased

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT03758690
BTL-After Childbirth

Details and patient eligibility

About

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

Enrollment

10 patients

Sex

Female

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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

  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Treatment Group
Experimental group
Description:
Treatment with the investigational device - High-Intensity Focused Electromagnetic (HIFEM) Field Device
Treatment:
Device: High-Intensity Focused Electromagnetic (HIFEM) Field Device

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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