Overview

This trial is active, not recruiting.

Conditions circumferential reduction, waist circumferential reduction
Treatments btl-9000 lllt, sham btl-9000 lllt
Sponsor BTL Industries Ltd.
Start date September 2013
End date December 2013
Trial size 40 participants
Trial identifier NCT02023385, BTL-9000 LLLT

Summary

Prospective, two-arm, randomized study of the effectiveness of the BTL-9000 LLLT in achieving 3 cm or greater average waist circumferential reduction in LLLT 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Subjects in the Low Level Laser Therapy (LLLT) group will be treated with the BTL-9000 LLLT
btl-9000 lllt BTL-9000 LowLevel Laser Therapy
Irradiation of adipocyte cells within the fat layer with BTL-9000 LLLT for the release of fat and lipids from these cells
(Placebo Comparator)
Subjects in the Placebo group with be treated with the sham BTL-9000 LLLT
sham btl-9000 lllt
Irradiation of adipocyte cells within the fat layer with sham BTL-9000 LLLT for the release of fat and lipids from these cells

Primary Outcomes

Measure
Waist Circumferential reduction
time frame: 30 days follow up after 8 twice-a-week treatments

Secondary Outcomes

Measure
Adverse Events
time frame: 6 months follow up

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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. - 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 - Photosensitivity disorder to 660 nm light - Active or recurrent cancer or current chemotherapy and/or radiation treatment

Additional Information

Official title Evaluation of the BTL-9000 Low Level Laser Therapy for the Waist Circumferential Reduction
Principal investigator Radina Denkova, MD
Description Prospective, randomized, blinded, two-arms study of waist circumferential reduction following 5 once-a-week treatments. One arm is the LLLT group of 25 subjects who are treated with the BTL-9000 LLLT and the other arm is the Placebo group of 15 subjects treated with the sham device. The objective of the study is to demonstrate the effectiveness of the BTL-9000 LLLT treatment in achieving average post-treatment waist circumferential 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by BTL Industries Ltd..