XP1000 RF Therapy on Waist Circumference Reduction

Circumferential Reduction Clinical Trial

Official title:

Effect of the XP1000 RF Therapy on Waist Circumference Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271672
• Other study ID #: XP1000RF
• Status: Completed
• Phase: N/A
• First received: October 20, 2014
• Last updated: June 17, 2015
• Start date: August 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: BTL Industries Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Circumferential Reduction
• Waist Circumferential Reduction

Intervention

Device:
• XP1000 RF
Treatment of adipose tissue within the fat layer with XP1000 RF.
• sham XP1000 RF
Treatment of adipose tissue within the fat layer with XP1000 RF.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BTL Industries Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes