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This study will evaluate the safety and performance of the BTL-899 device for non-invasive treatment of subcutaneous fat. The changes in the fat tissue related to the activity of caspase-3 will be assessed histologically. The study is a prospective single-center single-blinded two-arm study. The subjects will be enrolled and assigned into two study groups; Group A which will receive active treatment and Group B which receives sham treatment and will serve as a control to verify the treatment outcomes. Subjects will be required to complete only one (1) treatment visit and three (3) follow-up visits (at 8 hours, 24 hours and 7 days post treatment). All of the study subjects will receive the treatment (either active or sham) with the subject device.
At the baseline visit, health status will be assessed. Inclusion and exclusion criteria will be verified and informed consent will be signed. Punch biopsies from the treated abdominal area will be taken to examine the changes related to caspase-3 activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Histological evaluation of BTL-899 device´s effect on fat tissue | Experimental | This group will be treated with 100% of the treatment parameter settings |
|
| Sham treatment | Sham Comparator | This group will be treated with 5% of the treatment parameter settings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTL-899 | Device | BTL-899 treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Increased caspase-3 activity | Biopsy samples of the abdominal fat tissue will be processed for histological evaluation by a certified laboratory. Conventional staining will be used to determine the changes in the fat tissue related to the increase in caspase-3 activity, which is associated with elevated levels of fat tissue apoptosis, and to examine other morphological changes of treated tissue, in all collected samples. Post-treatment findings will be compared to the baseline. The results of both study groups will be compared as well. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment | Occurrence of adverse events | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Laser and Surgery Specialist, a Division of Schweiger Dermatology | Hackensack | New Jersey | 07601 | United States |
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