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Effect of the XP1100RF Therapy on Thighs Circumference Reduction | Clinical Trials | Clareo Health

COMPLETEDNA

Effect of the XP1100RF Therapy on Thighs Circumference Reduction

NCT02527369•BTL Industries Ltd.

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.

Eligibility

Age

22 - 70 years

Sex

ALL

Healthy Volunteers

Yes

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
+3 more criteria

Key Dates

Start Date

July 1, 2014

Primary Completion Date

March 1, 2015

Completion Date

March 1, 2015

Last Updated

July 13, 2020

Enrollment

ACTUAL participants

Conditions

Thighs Circumferential ReductionSubcutaneous Fat Cell Disruption

Interventions

XP1100RF

DEVICE