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It wasn't possible to recruit the desired number of patients.
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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 computed tomography 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. Computed tomography and weight measure will be conducted at every follow-up visit. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Treatment with the investigational device - High Intensity Focused ElectroMagnetic System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with High Intensity Focused ElectroMagnetic system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of the device assessed through photography evaluation | Photography evaluations with correct identification of pre-treatment images compared to post-treatment images. | 13 months |
| Effectiveness of the device assessed through change in adipose/muscle layer thickness | Change in adipose/muscle layer thickness between pre-treatment and post-treatment based on computed tomography measurements. | 13 months |
| Subject's satisfaction | 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. | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the device for non-invasive fat disruption | 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. | 13 months |
| Therapy comfort |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatologic Surgery Specialists | Macon | Georgia | 31217 | United States | ||
| Chicago Cosmetic Surgery and Dermatology |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Therapy comfort will be noted at the last therapy visit. Subjects will be asked to evaluate the agreement with the statement concerning the conformity of the study treatment. Subjects will be evaluating the agreement by choosing an answer on a scale between 1 (Strongly disagree) and 5 (Strongly agree). Based on a given answers, the therapy comfort will be calculated. |
| 3 months |
| Chicago |
| Illinois |
| 60654 |
| United States |