XP1000 RF Therapy on Waist Circumference Reduction

Effect of the XP1000 RF Therapy on Waist Circumference Reduction

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.

Study Overview

• Status: Completed
• Conditions: Circumferential Reduction; Waist Circumferential Reduction
• Intervention / Treatment: Device: XP1000 RF; Device: sham XP1000 RF

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.
• Investigators: Principal Investigator: Radina Denkova, MD, Aesthe Beauty Clinic

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: October 20, 2014
• First Submitted That Met QC Criteria: October 21, 2014
• First Posted (Estimate): October 22, 2014

Study Record Updates

• Last Update Posted (Estimate): June 18, 2015
• Last Update Submitted That Met QC Criteria: June 17, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: XP1000RF