XP1000 RF Therapy on Waist Circumference Reduction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of the XP1000 RF Therapy on Waist Circumference Reduction

Conditions
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Circumferential Reduction, Waist Circumferential Reduction

Intervention / Treatment
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* Device: XP1000 RF
* Device: sham XP1000 RF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XP1000 RF group<br>Subjects in the XP1000 RF group will be treated with the XP1000 RF device. | Device: XP1000 RF<br>* Treatment of adipose tissue within the fat layer with XP1000 RF.<br>|
| Sham Comparator: Sham group<br>Subjects in the Sham group will be treated with the sham XP1000 RF device. | Device: sham XP1000 RF<br>* Treatment of adipose tissue within the fat layer with XP1000 RF.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist Circumferential reduction | 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. | 30 days follow follow up after 4 once-a-week treatments | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | 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 | 1 month follow up | 
| Adverse Events | 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 | 3 months follow up |