Clinical trial NCT02023398: BTL-9000 High Frequency Therapy for the Waist Circumferential Reduction
Official title: Evaluation of the Effectiveness of the BTL-9000 High Frequency Therapy for the Waist Circumferential Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Circumferential Reduction
Waist Circumferential Reduction
Keywords: High Frequency
Waist circumferential reduction
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2013-12-30
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Waist Circumference Reduction
timeFrame: 1 month follow up after 5 once-a-week treatments
Secondary outcomes:
measure: Adverse Events
timeFrame: 1 month follow up
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: Polyklinika Mytna
Study officials:
affiliation: Polyklinaka Mytna
name: Iveta Hasova, MD
role: PRINCIPAL_INVESTIGATOR
References: