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The study will evaluate safety and efficacy of the BTL-703 device for the non-invasive lipolysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Treated group of subjects, serves as its own control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTL-703 (Treatment group) | Device | Treatment with BTL-703 device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Waist circumference reduction | The waist circumference measure will be conducted in accordance to the WHO STEPwise approach to surveillance (2008.) and NHLBI Obesity Education Initiative (2000.) recommendations. The waist circumference after the therapy will be compared to baseline. | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serious adverse events following the treatment | Occurrence of serious adverse events will be followed throughout the whole study. | 5 months |
| Photo evaluation | Correct identification of the pre- and post-treatment photos by blinded evaluators. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Georgi Petkov | Contact | 32 62 22 52 | +359 | petkov@btlnet.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aesthe Clinic | Recruiting | Sofia | Bulgaria |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| 5 months |
| Subject Satisfaction | Subject Satisfaction Questionnaire will be given to subjects at every follow-up visit. | 5 months |
| Therapy discomfort | Subject's discomfort (pain) level after each treatment will be assessed using the Discomfort Questionnaire. | 2 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |