Effect of the XP1100RF Therapy on Thighs Circumference Reduction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 38
- Primary Endpoint
- Thighs Circumference Reduction from Baseline at 30 days Follow Up
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Body Mass Index (BMI) of 20 to 35 kg/m
- •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
Arms & Interventions
XP1100RF group
Subjects in the XP1100RF group will be treated with the XP1100RF device.
Intervention: XP1100RF (Device)
Outcomes
Primary Outcomes
Thighs Circumference Reduction from Baseline at 30 days Follow Up
Time Frame: 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 Outcomes
- Adverse Events(3 months Follow Up)
- Subject satisfaction assessed by questionnaires(30 days Follow Up)
- Adverse Events(30 days Follow Up)