Trials / Completed
CompletedNCT04643275
Effect of BTL-899 Device for Non-invasive Lipolysis on Human Upper Arms
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- BTL Industries Ltd. · Industry
- Sex
- All
- Age
- 21 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
This study will evaluate the clinical safety and the performance of the BTL-899 device during the treatment of upper arms.
Detailed description
The aim of the study is to confirm the efficacy and the safety of the treatment. The efficacy (reduction of excess adipose tissue) will be assessed via correct identification of pre-treatment and 3-months follow-up images by at least two out of three independent blinded evaluators. The fat reduction will be also measured by means of ultrasound. Comfort and satisfaction will be assessed via standard questionnaires. Safety measures will include documentation of adverse events (AE) during and after the procedures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BTL-899 | Treatment with study device. |
Timeline
- Start date
- 2020-10-15
- Primary completion
- 2021-08-02
- Completion
- 2021-09-02
- First posted
- 2020-11-25
- Last updated
- 2021-09-09
Locations
1 site across 1 country: Bulgaria
Source: ClinicalTrials.gov record NCT04643275. Inclusion in this directory is not an endorsement.