An interventional study of BTL-899 and Sham in Improvement of Abdomen Appearance, sponsored by BTL Industries Ltd.. Status unknown at 1 site in Bulgaria. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-27.
Sponsored by BTL Industries Ltd. · Not applicable, Interventional, and Treatment
The study is a prospective single-blinded two-arms study that includes three treatment procedures and four follow-up visits
This study will evaluate the clinical efficacy and safety of the BTL-899 device for non-invasive lipolysis and circumference reduction of abdomen. The study is a prospective single-blinded two-arms study. The subjects will be enrolled and assigned into a two study groups. All subjects will complete three (3) treatment visits and will be invited to four (4) follow-up visits 1, 2, 3 and 6-months after the final treatment. 6-months follow-up visit is the optional one.
BTL Industries Ltd. is the lead sponsor of 77 studies on the registry; 5 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Device: BTL-899
Device: Sham
Treatment with BTL-899 device, 3 therapies
Sham treatment with BTL-899 device, 3 visits
Efficacy of the BTL-899 treatment for change in abdominal circumference
Comparison of change in abdominal circumference at the final follow-up visit between two study groups.
Time frame: 4 months
Occurrence of adverse events
The occurrence of adverse events will be followed throughout the whole study.
Time frame: 7 months
Efficacy of BTL-899 treatment for abdominal fat and circumference reduction, as assessed by two blinded evaluators
Evaluation of aesthetic improvement achieved by abdominal fat and circumference reduction using photographs before and after the treatment.
Time frame: 4 months
Efficacy of the BTL-899 treatment for change in abdominal circumference
Comparison of change in abdominal circumference at all study visits after the first therapy between two study groups.
Time frame: 4 months
Efficacy of the BTL-899 treatment for abdominal fat reduction
Comparison of fat reduction between two study groups using ultrasound images.
Time frame: 4 months
Subject's satisfaction with study treatment
Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire (5-point scale).
Time frame: 4 months
Therapy comfort during the study treatment.
Therapy comfort during the treatment evaluated through the Therapy Comfort Questionnaire (10-point scale).
Time frame: 1 month
Started Dec 2018 (actual). Primary completion is estimated for Dec 2019, 12 months after the start.
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This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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