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This study will evaluate the clinical efficacy and safety of a simultaneous treatment by repetitive pulse magnetic stimulation and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. 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 three (3) treatment visits and two to three follow-up visits. All of the study subjects will receive the treatment with the subject device.
This study will evaluate the clinical efficacy and safety of a simultaneous treatment by repetitive pulse magnetic stimulation and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. 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 three (3) treatment visits and two to three follow-up visits. All of the study subjects will receive the treatment with the subject device.
At the baseline visit MRI will be performed, subject's weight and waist circumference will be recorded. Photos of the treated area will be taken.
The treatment administration phase will consist of three (3) treatments, delivered once a week. The applicator will be applied over umbilicus and visible muscle contractions along with heating of the subcutaneous fat will be induced by the device.
At the last therapy visit, the subject's weight and waist circumference will be recorded, and photos of the treated area will be taken. In addition, subjects will receive Subject Satisfaction Questionnaire to fill in.
Safety measures will include documentation of adverse events (AE) including subject's experience of pain or discomfort after each procedure. Following each treatment administration and at all of the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment.
During the post-procedure visits (at 1-month and 3-month follow-up visits), the subjects will undergo MRI scanning. Also, subject's satisfaction will be noted and weight with waist circumference will be recorded. Photographs of the treated area will be taken. There will be an option of a 6-months follow-up visit, according to subject's availability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdominal Toning and Reduction of Subcutaneous Fat | Experimental | simultaneous treatment by repetitive pulse magnetic stimulation and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rPMS+RF | Device | The treatment administration phase will consist of three (3) treatments, delivered once a week. The applicator of the device will be applied over umbilicus and visible muscle contractions along with heating of the subcutaneous fat will be induced by the device. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of change in adipose and muscular layer thickness between pre-treatment and post-treatment based on MRI scans | MRI will be conducted at the baseline visit and all follow-up visits. The imaging will be conducted at the same surface area each time. Hospital-grade MRI device will be used to scan abdominal area of each subject. The MRI scan without any contrast agent will be performed, with the scanned body segment determined by vertebrae T12 and S1. Lateral cuts from 5 cm below the umbilicus and 5 cm above the umbilicus will be evaluated for the thickness of muscle and subcutaneous adipose tissue. | 4 months |
| Evaluation of change in adipose layer thickness between pre-treatment and post-treatment based on waist circumference measurements | Waist circumference measure will be conducted at the baseline visit, after last treatment and during follow-up visits. The waist circumference measure will be made at the top of the subject's iliac crest, with the tape held snugly, but not constricting, and at a level parallel to the floor. For the measurement, a stretch-resistant tape will be used. During the measuring, subject will stand with arms at the side, feet positioned close together, and weight evenly distributed across the feet. The subject will be instructed to relax and take a few deep, natural breaths before the actual measurement is made. The subjects will be measured in underwear only, after voiding the bladder. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of subject's satisfaction with the treatment using the Subject Satisfaction Questionnaire | The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant's satisfaction with the therapy outcome with answer "Strongly agree" being the most positive outcome and "Strongly disagree" the most negative. Subject satisfaction will be assessed after the last therapy visit and during the follow-up visits. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Care Physicians of Georgia | Macon | Georgia | 31217 | United States | ||
| Chicago Cosmetic Surgery and Dermatology |
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| 7 months |
| Safety of the device measured via the occurrence of adverse events or lack thereof | The occurrence of adverse events will be followed throughout the whole study. | 7 months |
| Chicago |
| Illinois |
| 60654 |
| United States |