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Completed

NCT Number: NCT03758690

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

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

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Key information

Conditions

Muscle Tone Increased Muscle Hypertonia Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Skin Care Physicians of Georgia, Macon, Georgia, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-Intensity Focused Electromagnetic (HIFEM) Field Device

Device

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

Primary outcomes

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

    Time frame: 7 months

    Evaluation of MRI images before and after the therapy procedure.

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

    Time frame: 7 months

    Evaluation of waist circumference measurements (in centimeters).

Secondary outcomes

  1. Subject's satisfaction with study treatment: Questionnaire

    Time frame: 7 months

    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.

  2. Determination of side effects and adverse events (AE) associated with the study device.

    Time frame: 7 months

    The occurrence of side effects and adverse events will be followed throughout the whole study

Sponsors and collaborators

Lead sponsor

BTL Industries Ltd.

Industry

Registry information

Official study title

Efficacy of Abdominal Treatment With High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 29, 2018
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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