XP1000 RF Therapy on Waist Circumference Reduction

NCT ID: NCT02271672

Last Updated: 2015-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-06-30

Brief Summary

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

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.

Conditions

Circumferential Reduction; Waist Circumferential Reduction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

XP1000 RF group

Subjects in the XP1000 RF group will be treated with the XP1000 RF device.

Group Type: EXPERIMENTAL

XP1000 RF

Intervention Type: DEVICE

Treatment of adipose tissue within the fat layer with XP1000 RF.

Sham group

Subjects in the Sham group will be treated with the sham XP1000 RF device.

Group Type: SHAM_COMPARATOR

sham XP1000 RF

Intervention Type: DEVICE

Treatment of adipose tissue within the fat layer with XP1000 RF.

Interventions

XP1000 RF

Treatment of adipose tissue within the fat layer with XP1000 RF.

Intervention Type: DEVICE

sham XP1000 RF

Treatment of adipose tissue within the fat layer with XP1000 RF.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BTL Industries Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Radina Denkova, MD

Role: PRINCIPAL_INVESTIGATOR

Aesthe Beauty Clinic

Other Identifiers

XP1000RF

Identifier Type: -

Identifier Source: org_study_id