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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
Sponsor:
Information provided by (Responsible Party):
BTL Industries Ltd.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Circumferential Reduction Waist Circumferential Reduction Device: BTL-9000 HFT Device: sham BTL-9000 HFT Not Applicable

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 Design
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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
Arms and Interventions
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Arm Intervention/treatment
Experimental: HFT group
Subjects in the High Frequency Therapy (HFT) group will be treated with the BTL-9000 HFT
 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
 Device: sham BTL-9000 HFT
sham deep tissue heating with BTL-9000 HFT in Placebo group


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Slovakia
Polyklinika Mytna
Bratislava, Slovakia
Sponsors and Collaborators
BTL Industries Ltd.
Investigators
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Principal Investigator: Iveta Hasova, MD Polyklinaka Mytna
More Information
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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
Keywords provided by BTL Industries Ltd.:
High Frequency
Waist circumferential reduction