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The study is a prospective two-arm, open-label, interventional study with four treatment procedures and two follow-up visits.
This study aims to evaluate the clinical safety and efficacy of the BTL-899 device for non-invasive lipolysis and fat reduction in the thigh and saddlebag area. This is a prospective, open-label, two-arm study; therefore the participants will be assigned to two study groups. Each participant will complete 4 treatment visits and 2 follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thighs circumference reduction | Experimental | The subjects will be enrolled and treated once per week. Both legs will be treated consecutively. The therapy will be applied simultaneously. |
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| Saddlebags fat thickness reduction | Experimental | The subjects will be enrolled and treated once per week. Both legs will be treated consecutively. The therapy will be applied consecutively too. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTL-899 | Device | Treatment with study device. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in Fat Thickness Measured via Ultrasound | To gather clinical evidence that the BTL-899 device is able to induce non-invasive lipolysis when used on thighs and saddlebags. The fat thickness changes will be measured by means of ultrasound. | 6 months |
| Participants' Satisfaction Measured Via Questionnaires | Evaluation of the participants' satisfaction with the therapy via Therapy Satisfaction Questionnaires. Global Aesthetic Improvement Scale (Quality of Life questionnaire) will be used where score "3" means "very much improved" and "-3" is "very much worse". | 6 months |
| Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire | The outcome will further be measured through the occurrence of adverse events or lack thereof. On Numerical Analog Scale (0-10), where 0 represents 'no pain' and 10 represents 'worst possible pain' select the level of pain experienced during the treatment. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aesthe Clinic | Sofia | 1700 | Bulgaria |
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