- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02023398
BTL-9000 High Frequency Therapy for the Waist Circumferential Reduction
September 17, 2014 updated by: BTL Industries Ltd.
Evaluation of the Effectiveness of the BTL-9000 High Frequency Therapy for the Waist Circumferential Reduction
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Bratislava, Slovakia
- Polyklinika Mytna
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HFT group
Subjects in the High Frequency Therapy (HFT) group will be treated with the BTL-9000 HFT
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Deep tissue heating with the BTL-9000 HFT for HFT group
Other Names:
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Placebo Comparator: Placebo group
Subjects in the Placebo group with be treated with the sham BTL-9000 HFT
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sham deep tissue heating with BTL-9000 HFT in Placebo group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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1 month follow up after 5 once-a-week treatments
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: 1 month follow up
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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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1 month follow up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Iveta Hasova, MD, Polyklinaka Mytna
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
December 20, 2013
First Submitted That Met QC Criteria
December 26, 2013
First Posted (Estimate)
December 30, 2013
Study Record Updates
Last Update Posted (Estimate)
September 19, 2014
Last Update Submitted That Met QC Criteria
September 17, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- BTL-9000 HFT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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