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

Efficacy of Abdominal Treatment With 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.

Study Overview

• Status: Completed
• Conditions: Muscle Tone Increased
• Intervention / Treatment: Device: High-Intensity Focused Electromagnetic (HIFEM) Field Device

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; Treatment with the investigational device - High-Intensity Focused Electromagnetic (HIFEM) Field Device	Device: High-Intensity Focused Electromagnetic (HIFEM) Field Device; The High-Intensity Focused Electromagnetic (HIFEM) Field device will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of the device for abdominal toning according to MRI images	Evaluation of MRI images before and after the therapy procedure.	7 months
Effectiveness of the device for abdominal toning according to waist circumference measurements	Evaluation of waist circumference measurements (in centimeters).	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 months
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	7 months

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2018
• Primary Completion (Actual): August 13, 2019
• Study Completion (Actual): January 2, 2020

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (Actual): November 29, 2018

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 22, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Muscle Hypertonia
• Other Study ID Numbers: BTL-After Childbirth

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No