Subcutaneous Fat Cell Disruption, Thighs Circumferential Reduction
Conditions
Keywords
Fat Reduction, Lipolysis
Brief summary
This study was designed to demonstrate safety and efficacy of the XP1100RF for non-invasive temporary reduction of thighs circumference by disruption of adipocyte cells.
Detailed description
This study is a prospective, single-arm, open label study of thighs circumference reduction following 4 treatment sessions delivered once a week over a 4-week period. The objective of the study is to demonstrate the effectiveness of the treatment after 30-day in achieving thighs circumference reduction of ≥1 cm relative to the base line assessment.
Interventions
DEVICEXP1100RF
Treatment of adipose tissue within the fat layer with XP1100RF 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 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Body Mass Index (BMI) of 20 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
* 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 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 |
|---|---|---|
| Thighs Circumference Reduction from Baseline at 30 days Follow Up | 30 days Follow Up | The primary efficacy outcome measure is set to be a minimum of 80% of subjects at 30-day follow up evaluation to show thighs circumference reduction of ≥1 cm below the gluteal fold relative to the base line assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 30 days Follow Up | 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. |
| Subject satisfaction assessed by questionnaires | 30 days Follow Up | Subject satisfaction as assessed by questionnaires administered at 30 days follow up. |
Outcome results
None listed