Effect of the XP1100RF Therapy on Thighs Circumference Reduction (NCT02527369) | Clinical Trial Compass
CompletedNot Applicable
Effect of the XP1100RF Therapy on Thighs Circumference Reduction
38 participantsStarted 2014-07
Plain-language 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.
Who can participate
Age range22 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 chemotherap…
What they're measuring
1
Thighs Circumference Reduction from Baseline at 30 days Follow Up