Circumferential Reduction, Waist Circumferential Reduction
Conditions
Brief summary
This study was designed to demonstrate safety and efficacy of the XP1000 RF for non-invasive temporary reduction of waist circumference by disruption of adipocyte cells.
Detailed description
This study is a prospective, double-blinded, randomized, two-arm sham-controlled study of circumferential waist 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 and 90-day Follow Up in achieving waist circumference reduction of ≥3 cm across the waist line relative to the base line assessment and their mean waist circumferential reduction is ≥1 cm than the average circumferential reduction of sham group.
Interventions
DEVICEXP1000 RF
Treatment of adipose tissue within the fat layer with XP1000 RF.
DEVICEsham XP1000 RF
Treatment of adipose tissue within the fat layer with XP1000 RF.
Sponsors
BTL Industries Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 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 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 * Active or recurrent cancer or current chemotherapy and/or radiation treatment * Negative affection to heat
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Waist Circumferential reduction | 30 days follow follow up after 4 once-a-week treatments | The primary efficacy outcome measure is set to be a minimum of 80% of subjects in the XP1000 RF group at 30-day follow up evaluation to show waist circumference reduction of ≥3 cm across the waist line relative to the base line assessment and their mean waist circumferential reduction is ≥1 cm than the average circumferential reduction of Sham group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 1 month 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 |
Outcome results
None listed