Clinical trial NCT02023385: BTL-9000 Low Level Laser Therapy for the Waist Circumferential Reduction
Official title: Evaluation of the BTL-9000 Low Level Laser Therapy for the Waist Circumferential Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Circumferential Reduction
Waist Circumferential Reduction
Keywords: Low Level Laser Therapy
LLLT
Waist circumferential reduction
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2013-12-30
Enrollment: 40
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 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.

Detailed 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.

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.
* 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

Primary outcomes:
measure: Waist Circumferential reduction
timeFrame: 30 days follow up after 8 twice-a-week treatments
Secondary outcomes:
measure: Adverse Events
timeFrame: 1 month follow up
Other outcomes:
Locations:
Study officials:
affiliation: Dermatologic Clinic
name: Radina Denkova, MD
role: PRINCIPAL_INVESTIGATOR
References: