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Trial record 76 of 45862 for:    intensity

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

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ClinicalTrials.gov Identifier: NCT03758690
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : November 29, 2018
Sponsor:
Collaborator:
BTL Industries JSC
Information provided by (Responsible Party):
BTL Industries Ltd.

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

Condition or disease Intervention/treatment Phase
Muscle Tone Increased Device: High-Intensity Focused Electromagnetic (HIFEM) Field Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Abdominal Treatment With High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth
Actual Study Start Date : November 9, 2018
Estimated Primary Completion Date : September 9, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Childbirth

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03758690


Locations
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United States, Georgia
Skin Care Physicians of Georgia Recruiting
Macon, Georgia, United States, 31217
Contact: David Kent, MD    478-742-2180    dekent@dsspc.com   
United States, Illinois
Chicago Cosmetic Surgery and Dermatology Recruiting
Chicago, Illinois, United States, 60654
Contact: Carolyn Jacob, MD    312-245-9965    info@chicagodermatology.com   
Sponsors and Collaborators
BTL Industries Ltd.
BTL Industries JSC

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Responsible Party: BTL Industries Ltd.
ClinicalTrials.gov Identifier: NCT03758690     History of Changes
Other Study ID Numbers: BTL-After Childbirth
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms