Effect of the XP1100RF Therapy on Thighs Circumference Reduction

BTL

Status: Completed

Conditions: Subcutaneous Fat Cell Disruption; Thighs Circumferential Reduction

Treatments: Device: XP1100RF

Study type: Interventional

Funder types: Industry

Identifiers

NCT02527369

Version1-713/2/2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 22 to 70 years old

Volunteers: Accepts Healthy Volunteers

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 chemotherapy and/or radiation treatment
• Negative affection to heat

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

XP1100RF group

Experimental group

Description:

Subjects in the XP1100RF group will be treated with the XP1100RF device.

Treatment:

Device: XP1100RF