BTL-9000 High Frequency Therapy for the Waist Circumferential Reduction

NCT ID: NCT02023398

Last Updated: 2014-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2013-12-31

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.

Conditions

Circumferential Reduction; Waist Circumferential Reduction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HFT group

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

Group Type: EXPERIMENTAL

BTL-9000 HFT

Intervention Type: DEVICE

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

Placebo group

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

Group Type: PLACEBO_COMPARATOR

sham BTL-9000 HFT

Intervention Type: DEVICE

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

Interventions

BTL-9000 HFT

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

Intervention Type: DEVICE

sham BTL-9000 HFT

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

Intervention Type: DEVICE

Other Intervention Names

BTL-9000 High Frequency Therapy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BTL Industries Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Iveta Hasova, MD

Role: PRINCIPAL_INVESTIGATOR

Polyklinaka Mytna

Locations

Polyklinika Mytna

Bratislava, , Slovakia

Countries

Slovakia

Other Identifiers

BTL-9000 HFT

Identifier Type: -

Identifier Source: org_study_id