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
About this trial
This is an interventional treatment trial for Muscle Tone Increased
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
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
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
Learn more about this trial
High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth
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