An interventional study of BTL-899 in Fat Burn, sponsored by BTL Industries Ltd.. Completed at 1 site in Bulgaria. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-09.
Sponsored by BTL Industries Ltd. · Not applicable, Interventional, and Treatment
This study will evaluate the clinical safety and the performance of the BTL-899 device during the treatment of upper arms.
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.
BTL Industries Ltd. is the lead sponsor of 71 studies on the registry; 4 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The treatment administration phase consists of four (4) treatment visits, delivered 5- 10 - days apart. Each therapy session will last 30 minutes. Follow-ups visits at 1 month and 3 months after the final treatment will be held.
Device: BTL-899
Treatment with study device.
Statistically significant reduction of fat thickness in the upper arms evaluated by photographs
To gather clinical evidence that the BTL-899 device is able to induce non-invasive lipolysis when used on upper arms. The primary efficacy outcome measure is a minimum 75% of the subjects' pre-treatment and 3-months follow-up images to be correctly identified by at least two of three independent blinded evaluators.
Time frame: 5 months
Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire
Assessment the safety of the BTL-899 device when used for non-invasive lipolysis of the upper arms via questionnaires filled in by the participants following each therapy session. 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. The outcome will further be measured through the occurrence of adverse events or lack thereof.
Time frame: 7 months
Evaluation of the participants' satisfaction with the therapy evaluated via standard questionnaires
Evaluation of the participants' satisfaction with the therapy and the results. ● Minimum 80% of treated subjects to report satisfaction (level satisfied and higher) with the therapy.
Time frame: 5 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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BTL Industries Ltd.