XP1000 RF Therapy on Waist Circumference Reduction

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.

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