An interventional study of BTL-899 in Fat Burn, sponsored by BTL Industries Ltd.. Completed at 6 sites in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-26.
Sponsored by BTL Industries Ltd. · Not applicable, Interventional, and Treatment
This study will evaluate the clinical efficacy and performance of the BTL-899 device for changes in subcutaneous fat and muscle tissue in the lateral abdomen region (also referred to as flanks or "love handles"). The study is a prospective, multi-center, open-label, single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the subject device.
At the baseline visit, MRI imaging will be performed; the subject's weight and waist circumference will be recorded. Digital photographs of the treated area will be taken.
The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899 will be applied over the area of flanks. The device will induce visible muscle contractions along with heating of the subcutaneous fat. Each therapy session will last 30 minutes.
At the last therapy visit, the subject's weight and waist circumference will be recorded, and digital photographs of the treated area will be taken. In addition, subjects will receive Therapy Comfort and Subject Satisfaction Questionnaire to fill in.
Safety measures will include documentation of adverse events (AE), which will be assessed after each procedure and at all of the follow-up visits.
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.
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Exclusion Criteria:
Evaluation of change in adipose and muscle layer thickness between pre-treatment and post-treatment based on MRI imaging and waist circumference measurements
Device: BTL-899
Treatment with applicators C4/C5 to the BTL-899 system.
Evaluation of change in adipose and muscle layer thickness
The changes in muscles and adipose tissue of the treatment area between pre-treatment and post-treatment will be evaluated according to the MRI imaging and waist circumference measurements. Using the obtained MRI images, changes in adipose and muscular tissues before and after the therapy sessions will be compared for every participant according to the study phase. The circumference before and after the study therapy will be compared for each subject, according to the study phase. The circumference will be measured to identify any change in abdominal circumference related to changes in adipose tissue and muscle thickness. When applicable, the statistical analysis will be conducted in Microsoft Excel spreadsheet software with a level of significance set to 5%.
Time frame: 4 months
Subject Satisfaction
The 5-point Likert scale Subject Satisfaction Questionnaire will be used for an analysis of the subject's opinion of the therapy results, where the best possible answer would be "strongly agree" and the worst "strongly disagree".
Time frame: 4 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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BTL Industries Ltd.