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Prospective, two-arm, randomized study of the effectiveness of the BTL-9000 HFT in achieving 3 cm or greater average waist circumferential reduction in HFT group of subjects relative to the base line and 1 cm or greater reduction relative to the average waist circumferential reduction of the Placebo group.
Prospective, randomized, blinded, two-arms study of waist circumferential reduction following 5 once-a-week treatments. One arm is the HFT group of 64 subjects who are treated with the BTL-9000 HFT and the other arm is the Placebo group of 38 subjects treated with the sham device. The objective of the study is to demonstrate the effectiveness of the BTL-9000 HFT treatment in achieving average post-treatment waist circumference reduction of 3 cm or greater across the waistline relative to the baseline assessment and of 1 cm or greater than the average waist circumferential reduction of the Placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HFT group | Experimental | Subjects in the High Frequency Therapy (HFT) group will be treated with the BTL-9000 HFT |
|
| Placebo group | Placebo Comparator | Subjects in the Placebo group with be treated with the sham BTL-9000 HFT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTL-9000 HFT | Device | Deep tissue heating with the BTL-9000 HFT for HFT group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Waist Circumference Reduction | The subjects in the HFT group whose average post-treatment waist circumference shows reduction of 3 cm or greater across the waistline relative to the base line assessment and their mean waist circumferential reduction is 1 cm or greater than the average circumferential reduction of Placebo group are considered to meet the study primary outcome success criteria. | 1 month follow up after 5 once-a-week treatments |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Absence of adverse events (AE) associated with the treatment procedure. Safety evaluations of skin reaction in the treatment area would be conducted at every treatment and follow up visits | 1 month follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iveta Hasova, MD | Polyklinaka Mytna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Polyklinika Mytna | Bratislava | Slovakia |
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| sham BTL-9000 HFT | Device | sham deep tissue heating with BTL-9000 HFT in Placebo group |
|