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

Primary Purpose

Muscle Tone Increased

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-Intensity Focused Electromagnetic (HIFEM) Field Device
Sponsored by
BTL Industries Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Tone Increased

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Skin Care Physicians of Georgia
  • Chicago Cosmetic Surgery and Dermatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

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

Outcomes

Primary Outcome Measures

Effectiveness of the device for abdominal toning according to MRI images
Evaluation of MRI images before and after the therapy procedure.
Effectiveness of the device for abdominal toning according to waist circumference measurements
Evaluation of waist circumference measurements (in centimeters).

Secondary Outcome Measures

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.
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

Full Information

First Posted
November 26, 2018
Last Updated
May 22, 2020
Sponsor
BTL Industries Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03758690
Brief Title
High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth
Official Title
Efficacy of Abdominal Treatment With High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 25, 2018 (Actual)
Primary Completion Date
August 13, 2019 (Actual)
Study Completion Date
January 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BTL Industries Ltd.

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Tone Increased

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Treatment with the investigational device - High-Intensity Focused Electromagnetic (HIFEM) Field Device
Intervention Type
Device
Intervention Name(s)
High-Intensity Focused Electromagnetic (HIFEM) Field Device
Intervention Description
The High-Intensity Focused Electromagnetic (HIFEM) Field device will be applied.
Primary Outcome Measure Information:
Title
Effectiveness of the device for abdominal toning according to MRI images
Description
Evaluation of MRI images before and after the therapy procedure.
Time Frame
7 months
Title
Effectiveness of the device for abdominal toning according to waist circumference measurements
Description
Evaluation of waist circumference measurements (in centimeters).
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Subject's satisfaction with study treatment: Questionnaire
Description
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
Title
Determination of side effects and adverse events (AE) associated with the study device.
Description
The occurrence of side effects and adverse events will be followed throughout the whole study
Time Frame
7 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Skin Care Physicians of Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Chicago Cosmetic Surgery and Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States

12. IPD Sharing Statement

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

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