BTL-9000 High Frequency Therapy for the Waist Circumferential Reduction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of the Effectiveness of the BTL-9000 High Frequency Therapy for the Waist Circumferential Reduction

Conditions
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Circumferential Reduction, Waist Circumferential Reduction

Intervention / Treatment
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* Device: BTL-9000 HFT
* Device: sham BTL-9000 HFT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFT group<br>Subjects in the High Frequency Therapy (HFT) group will be treated with the BTL-9000 HFT | Device: BTL-9000 HFT<br>* Deep tissue heating with the BTL-9000 HFT for HFT group<br>* Other names: BTL-9000 High Frequency Therapy;|
| Placebo Comparator: Placebo group<br>Subjects in the Placebo group with be treated with the sham BTL-9000 HFT | Device: sham BTL-9000 HFT<br>* sham deep tissue heating with BTL-9000 HFT in Placebo group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist Circumference Reduction | The subjects in the HFT group whose average post-treatment waist circumference shows reduction of 3 cm or greater across the waistline relative to the base line assessment and their mean waist circumferential reduction is 1 cm or greater than the average circumferential reduction of Placebo group are considered to meet the study primary outcome success criteria. | 1 month follow up after 5 once-a-week treatments | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Absence of adverse events (AE) associated with the treatment procedure. Safety evaluations of skin reaction in the treatment area would be conducted at every treatment and follow up visits | 1 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Frequency, Waist circumferential reduction