XP1000 RF Therapy on Waist Circumference Reduction
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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