BTL-9000 High Frequency Therapy for the Waist Circumferential Reduction

Circumferential Reduction Clinical Trial

Official title:

Evaluation of the Effectiveness of the BTL-9000 High Frequency Therapy for the Waist Circumferential Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023398
• Other study ID #: BTL-9000 HFT
• Status: Completed
• Phase: N/A
• First received: December 20, 2013
• Last updated: September 17, 2014
• Start date: September 2013
• Est. completion date: December 2013

Study information

• Verified date: September 2014
• Source: BTL Industries Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovakia: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Circumferential Reduction
• Waist Circumferential Reduction

Intervention

Device:
• BTL-9000 HFT
Deep tissue heating with the BTL-9000 HFT for HFT group
• sham BTL-9000 HFT
sham deep tissue heating with BTL-9000 HFT in Placebo group

Locations

Country	Name	City	State
Slovakia	Polyklinika Mytna	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
BTL Industries Ltd.

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month follow up after 5 once-a-week treatments	No
Secondary	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	1 month follow up	Yes