Obesity, Overweight
Conditions
Brief summary
The study will evaluate safety and efficacy of the BTL-703 device for the non-invasive lipolysis.
Interventions
Treatment with BTL-703 device
Sponsors
BTL Industries Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 22 years * Voluntarily signed informed consent form
Exclusion criteria
* Implanted electronic device such as a cardiac pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, etc. * 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 thighs or buttocks 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 * Active or recurrent cancer or current chemotherapy and/or radiation treatment * Negative affection to heat
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Waist circumference reduction | 5 months | The waist circumference measure will be conducted in accordance to the WHO STEPwise approach to surveillance (2008.) and NHLBI Obesity Education Initiative (2000.) recommendations. The waist circumference after the therapy will be compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious adverse events following the treatment | 5 months | Occurrence of serious adverse events will be followed throughout the whole study. |
| Photo evaluation | 5 months | Correct identification of the pre- and post-treatment photos by blinded evaluators. |
| Subject Satisfaction | 5 months | Subject Satisfaction Questionnaire will be given to subjects at every follow-up visit. |
| Therapy discomfort | 2 months | Subject's discomfort (pain) level after each treatment will be assessed using the Discomfort Questionnaire. |
Countries
Bulgaria
Contacts
Primary ContactGeorgi Petkov
Outcome results
None listed