High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03758690|
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : November 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Muscle Tone Increased||Device: High-Intensity Focused Electromagnetic (HIFEM) Field Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- Effectiveness of the device for abdominal toning according to waist circumference measurements [ Time Frame: 7 months ]Evaluation of waist circumference measurements (in centimeters).
- 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.
- 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
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
|United States, Georgia|
|Skin Care Physicians of Georgia||Recruiting|
|Macon, Georgia, United States, 31217|
|Contact: David Kent, MD 478-742-2180 firstname.lastname@example.org|
|United States, Illinois|
|Chicago Cosmetic Surgery and Dermatology||Recruiting|
|Chicago, Illinois, United States, 60654|
|Contact: Carolyn Jacob, MD 312-245-9965 email@example.com|