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Evaluation of HIFEM treatments for strengthening and toning of arms, lower limbs and oblique muscles.
This study will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of arm, lower limb and oblique muscles. The study is a prospective multi-center open-label four-arm study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biceps circumference reduction | Experimental | This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of biceps brachii. |
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| Triceps circumference reduction | Experimental | This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of triceps brachii. |
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| Lower limb circumference reduction | Experimental | This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of muscles in lower limbs. |
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| Oblique muscles toning | Experimental | This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of oblique muscles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTL 799-2 | Device | High power magnet system |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in adipose and muscle tissue measured via ultrasound imaging | To determine the effectiveness of the device for strengthening and toning of arms, lower limbs and oblique muscles through changes in surrounding tissues, measured via ultrasound imaging. Using the obtained images, change in adipose and muscular tissues before and after the therapy sessions will be compared for every participant according to the study phase. | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's satisfaction measured via questionnaires | To determine the patient's satisfaction with study treatment for non-invasive strengthening and toning of arms, lower limbs and oblique muscles.The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant's satisfaction with the therapy outcome where the level of agreement between "strongly agree" and "strongly disagree" should indicate the participant's satisfaction with the therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plastic Surgical Associates | Fort Collins | Colorado | 80525 | United States | ||
| Juva Skin & Laser Center |
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| ID | Term |
|---|---|
| D009122 | Muscle Hypertonia |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| 7 months |
| Incidence Of Treatment-Related Adverse Events | To determine side effects and adverse events (AE) associated with the BTL 799-2 treatment of the arms, lower limbs and oblique muscles. Safety outcomes will include an evaluation of the treatment area to assess and evaluate the following:
| 7 months |
| New York |
| New York |
| 11377 |
| United States |
| D013568 | Pathological Conditions, Signs and Symptoms |