BTL-9000 High Frequency Therapy for the Waist Circumferential Reduction
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ClinicalTrials.gov Identifier: NCT02023398 |
Recruitment Status :
Completed
First Posted : December 30, 2013
Last Update Posted : September 19, 2014
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Condition or disease | Intervention/treatment | Phase |
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Circumferential Reduction Waist Circumferential Reduction | Device: BTL-9000 HFT Device: sham BTL-9000 HFT | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 102 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of the Effectiveness of the BTL-9000 High Frequency Therapy for the Waist Circumferential Reduction |
Study Start Date : | September 2013 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | December 2013 |
Arm | Intervention/treatment |
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Experimental: HFT group
Subjects in the High Frequency Therapy (HFT) group will be treated with the BTL-9000 HFT
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Device: BTL-9000 HFT
Deep tissue heating with the BTL-9000 HFT for HFT group
Other Name: BTL-9000 High Frequency Therapy |
Placebo Comparator: Placebo group
Subjects in the Placebo group with be treated with the sham BTL-9000 HFT
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Device: sham BTL-9000 HFT
sham deep tissue heating with BTL-9000 HFT in Placebo group |
- Waist Circumference Reduction [ Time Frame: 1 month follow up after 5 once-a-week treatments ]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.
- Adverse Events [ Time Frame: 1 month follow up ]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

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02023398
Slovakia | |
Polyklinika Mytna | |
Bratislava, Slovakia |
Principal Investigator: | Iveta Hasova, MD | Polyklinaka Mytna |
Responsible Party: | BTL Industries Ltd. |
ClinicalTrials.gov Identifier: | NCT02023398 |
Other Study ID Numbers: |
BTL-9000 HFT |
First Posted: | December 30, 2013 Key Record Dates |
Last Update Posted: | September 19, 2014 |
Last Verified: | September 2014 |
High Frequency Waist circumferential reduction |