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The study is a prospective single-blinded two-arms study that includes three treatment procedures and four follow-up visits
This study will evaluate the clinical efficacy and safety of the BTL-899 device for non-invasive lipolysis and circumference reduction of abdomen. The study is a prospective single-blinded two-arms study. The subjects will be enrolled and assigned into a two study groups. All subjects will complete three (3) treatment visits and will be invited to four (4) follow-up visits 1, 2, 3 and 6-months after the final treatment. 6-months follow-up visit is the optional one.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTL-899 Therapy Arm | Experimental |
| |
| Sham Arm | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTL-899 | Device | Treatment with BTL-899 device, 3 therapies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the BTL-899 treatment for change in abdominal circumference | Comparison of change in abdominal circumference at the final follow-up visit between two study groups. | 4 months |
| Occurrence of adverse events | The occurrence of adverse events will be followed throughout the whole study. | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of BTL-899 treatment for abdominal fat and circumference reduction, as assessed by two blinded evaluators | Evaluation of aesthetic improvement achieved by abdominal fat and circumference reduction using photographs before and after the treatment. | 4 months |
| Efficacy of the BTL-899 treatment for change in abdominal circumference |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr-Denkova Dermatology | Sofia | 1700 | Bulgaria |
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| Sham |
| Device |
Sham treatment with BTL-899 device, 3 visits |
|
Comparison of change in abdominal circumference at all study visits after the first therapy between two study groups. |
| 4 months |
| Efficacy of the BTL-899 treatment for abdominal fat reduction | Comparison of fat reduction between two study groups using ultrasound images. | 4 months |
| Subject's satisfaction with study treatment | Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire (5-point scale). | 4 months |
| Therapy comfort during the study treatment. | Therapy comfort during the treatment evaluated through the Therapy Comfort Questionnaire (10-point scale). | 1 month |