BTL-9000 High Frequency Therapy for the Waist Circumferential Reduction
This trial is active, not recruiting.
|Conditions||circumferential reduction, waist circumferential reduction|
|Treatments||btl-9000 hft, sham btl-9000 hft|
|Sponsor||BTL Industries Ltd.|
|Start date||September 2013|
|End date||December 2013|
|Trial size||102 participants|
|Trial identifier||NCT02023398, BTL-9000 HFT|
Prospective, two-arm, randomized study of the effectiveness of the BTL-9000 HFT in achieving 3 cm or greater average waist circumferential reduction in HFT group of subjects relative to the base line and 1 cm or greater reduction relative to the average waist circumferential reduction of the Placebo group.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, outcomes assessor)|
Waist Circumference Reduction
time frame: 1 month follow up after 5 once-a-week treatments
time frame: 6 month follow up
Male or female participants from 18 years up to 70 years old.
Inclusion Criteria: - Subjects 18-70 years of age of both gender with excess adipose tissue in the abdomen area - Body Mass Index (BMI) of 25 to 35 kg/m2. - Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss during study participation. - Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation. Exclusion Criteria: - - Diabetics dependent on insulin or oral hypoglycemic medications - Known cardiovascular disease such as arrhythmias, congestive heart failure - Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers. - Implanted electronic device such as a cardiac pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, etc. - Prior surgical interventions for body sculpting of abdomen such as liposuction - Medical, physical or other contraindications for body sculpting/ weight loss - Current use of medication known to affect weight levels and/or cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent - Any medical condition known to affect weight levels and/or to cause bloating or swelling - Active infection, wound or other external trauma to the area to be treated - Pregnant, breast feeding, or planning pregnant before the end of the study - Serious mental health illness - Negative affection to heat - Active or recurrent cancer or current chemotherapy and/or radiation treatment
|Official title||Evaluation of the Effectiveness of the BTL-9000 High Frequency Therapy for the Waist Circumferential Reduction|
|Principal investigator||Iveta Hasova, MD|
|Description||Prospective, randomized, blinded, two-arms study of waist circumferential reduction following 5 once-a-week treatments. One arm is the HFT group of 64 subjects who are treated with the BTL-9000 HFT and the other arm is the Placebo group of 38 subjects treated with the sham device. The objective of the study is to demonstrate the effectiveness of the BTL-9000 HFT treatment in achieving average post-treatment waist circumference reduction of 3 cm or greater across the waistline relative to the baseline assessment and of 1 cm or greater than the average waist circumferential reduction of the Placebo group.|
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