Fat Reduction Induced by Magnetic Device - Ultrasonographic Evaluation
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03537716|
Recruitment Status : Withdrawn (It wasn't possible to recruit the desired number of patients.)
First Posted : May 25, 2018
Last Update Posted : September 14, 2020
The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and four follow-up visits, 1 month, 3, 6 and 12 months after the final treatment.
At the baseline visit photographs of the abdomen will be taken. In addition, adipose/muscle layer thickness will be measured with the ultrasound and the subject's weight will be recorded. In addition, at the last therapy visit, subjects will receive Subject Satisfaction and Therapy Comfort Questionnaires to fill in.
Safety measures will include documentation of adverse events (AE) including subject's experience of pain or discomfort after the procedure. Following each treatment administration and at the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment.
Post-procedure evaluation (follow-up visits) will be conducted 1 month, 3, 6 and 12 months after the final treatment. An ultrasound imaging and weight measure will be conducted. Also, subject's satisfaction will be noted. During the first (1 month), third (6 months) and last (12 months) follow-up visits, photographs of abdomen will be taken.
|Condition or disease||Intervention/treatment||Phase|
|Fat Burn||Device: Treatment with High Intensity Focused ElectroMagnetic system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) for Fat Disruption of the Abdomen|
|Actual Study Start Date :||December 15, 2017|
|Estimated Primary Completion Date :||May 15, 2019|
|Estimated Study Completion Date :||June 15, 2019|
Experimental: Treatment Group
Treatment with the investigational device - High Intensity Focused ElectroMagnetic system
Device: Treatment with High Intensity Focused ElectroMagnetic system
The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the abdomen area. Visible contractions will be induced by the device.
- Effectiveness of the device assessed through photographic evaluation [ Time Frame: 13 months ]Photographic evaluations with correct identification of pre-treatment images compared to post-treatment images.
- Effectiveness of the device assessed through change in adipose layer thickness [ Time Frame: 13 months ]Change in adipose layer thickness between pre-treatment and post-treatment based on ultrasound measurements
- Subject's satisfaction [ Time Frame: 13 months ]The 5-point Likert scale Subject Satisfaction Questionnaire will be used for an analysis of the subject's opinion of the therapy results. Subjects will be evaluating agreement with three different statements (concerning satisfaction with therapy results and appearance of abdominal area after therapy) by choosing an answer on a scale between 1 (Strongly disagree) and 5 (Strongly agree). Minimally 80% of the treated subjects should report the agreement with all three statements given in the questionnaire (answers "Agree" and "Strongly agree") in order to claim subject's satisfaction with the therapy outcome.
- Safety of the device for non-invasive fat disruption [ Time Frame: 13 months ]
The secondary objective of the study is to determine side effects and adverse events (AE) associated with the treatment of the abdominal area.
The occurrence of adverse events will be followed throughout the whole study.
- Therapy comfort [ Time Frame: 3 months ]Therapy comfort will be noted at the last therapy visit.
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): NCT03537716
|United States, New York|
|JUVA Skin & Laser Center|
|New York, New York, United States, 10022|
|United States, Pennsylvania|
|Center for SmartLipo and Plastic Surgery|
|Langhorne, Pennsylvania, United States, 19047|
|Dermasense Dermatology Clinic|
|Burgas, Bulgaria, 8000|