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CompletedNCT02023398Updated Sep 19, 2014

BTL-9000 High Frequency Therapy for the Waist Circumferential Reduction

An interventional study of BTL-9000 HFT and sham BTL-9000 HFT in Circumferential Reduction and Waist Circumferential Reduction, sponsored by BTL Industries Ltd.. Completed at 1 site in Slovakia. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-19.

Sponsored by BTL Industries Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Circumferential Reduction
  • Waist Circumferential Reduction

Keywords

  • High Frequency
  • Waist circumferential reduction
03

In context

Lead sponsor

BTL Industries Ltd. is the lead sponsor of 77 studies on the registry; 5 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    HFT group

    Subjects in the High Frequency Therapy (HFT) group will be treated with the BTL-9000 HFT

    Device: BTL-9000 HFT

  • Placebo comparator
    Placebo group

    Subjects in the Placebo group with be treated with the sham BTL-9000 HFT

    Device: sham BTL-9000 HFT

Interventions

  • DeviceBTL-9000 HFT

    Deep tissue heating with the BTL-9000 HFT for HFT group

    Also known as: BTL-9000 High Frequency Therapy

  • Devicesham BTL-9000 HFT

    sham deep tissue heating with BTL-9000 HFT in Placebo group

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 month follow up after 5 once-a-week treatments

Secondary outcomes

  1. 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

    Time frame: 1 month follow up

07

Study locations

1 site
  • Polyklinika Mytna
    Bratislava, Slovakia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02023398
Responsible party
Sponsor
First posted
Dec 30, 2013
Start date
Sep 2013
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Sep 19, 2014

Study contacts

Iveta Hasova, MD
principal investigator · Polyklinaka Mytna

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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