XP1000 RF Therapy on Waist Circumference Reduction

NCT02271672 | Completed

• 1 other identifier: XP1000RF
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Circumferential Reduction; Waist Circumferential Reduction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adverse Events

  1 month follow up

• Adverse Events

  3 months follow up

Study Arms (2)

XP1000 RF group

EXPERIMENTAL

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

Device: XP1000 RF

Sham group

SHAM COMPARATOR

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

Device: sham XP1000 RF

Interventions

XP1000 RF DEVICE

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

XP1000 RF group

sham XP1000 RF DEVICE

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

Sham group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Officials

• Radina Denkova, MD

  Aesthe Beauty Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 22, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 18, 2015

Record last verified: 2015-06