Non-invasive Lipolysis on Human Thighs and Saddlebags

Effect on BTL-899 Device for Non-invasive Lipolysis on Human Thighs and Saddlebags

The study is a prospective two-arm, open-label, interventional study with four treatment procedures and two follow-up visits.

Study Overview

• Status: Completed
• Conditions: Adipose Tissue Reduction
• Intervention / Treatment: Device: BTL-899

Detailed Description

This study aims to evaluate the clinical safety and efficacy of the BTL-899 device for non-invasive lipolysis and fat reduction in the thigh and saddlebag area. This is a prospective, open-label, two-arm study; therefore the participants will be assigned to two study groups. Each participant will complete 4 treatment visits and 2 follow-up visits.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1700
    • Aesthe Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Body Mass Index (BMI) of 20 to 35 kg/m2.
• Visible excess of adipose tissue at the treatment sites (ARM 1 - thigh area; ARM 2 - saddlebags area).
• 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.
• No procedure for fat reduction (including cellulite treatment) in the last six months.
• Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting a significant change of weight in either direction during study participation.
• Age between 21 and 70 years.

Exclusion Criteria:

• Electronic implants (such as intrauterine device, cardiac pacemakers, defibrillators, and neurostimulators)
• Cardiovascular diseases
• Vascular diseases (such as chronic venous insufficiency, deep venous thrombosis, varicose veins, etc.)
• Femoral or inguinal hernia
• Disturbance of temperature or pain perception
• Pulmonary insufficiency
• Metal implants
• Drug pumps
• Malignant tumor
• Hemorrhagic conditions
• Septic conditions and empyema
• Acute inflammations
• Systemic or local infection such as osteomyelitis and tuberculosis
• Contagious skin disease
• Elevated body temperature
• Pregnancy
• Breastfeeding
• Injured or otherwise impaired muscles
• Scars, open lesions, and wounds at the treatment area
• Basedow's disease
• Previous liposuction in the treatment area in the last six months
• Unstable weight within the last 6 months (change in weight ± 3%)
• Previous body contouring or cellulite treatments in the thighs area in the last six months
• Any other disease or condition at the investigator's discretion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thighs circumference reduction; The subjects will be enrolled and treated once per week. Both legs will be treated consecutively. The therapy will be applied simultaneously.	Device: BTL-899; Treatment with study device.
Experimental: Saddlebags fat thickness reduction; The subjects will be enrolled and treated once per week. Both legs will be treated consecutively. The therapy will be applied consecutively too.	Device: BTL-899; Treatment with study device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Fat Thickness Measured via Ultrasound	To gather clinical evidence that the BTL-899 device is able to induce non-invasive lipolysis when used on thighs and saddlebags. The fat thickness changes will be measured by means of ultrasound.	6 months
Participants' Satisfaction Measured Via Questionnaires	Evaluation of the participants' satisfaction with the therapy via Therapy Satisfaction Questionnaires. Global Aesthetic Improvement Scale (Quality of Life questionnaire) will be used where score "3" means "very much improved" and "-3" is "very much worse".	6 months
Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire	The outcome will further be measured through the occurrence of adverse events or lack thereof. On Numerical Analog Scale (0-10), where 0 represents 'no pain' and 10 represents 'worst possible pain' select the level of pain experienced during the treatment.	6 months

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2020
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): November 13, 2020

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (Actual): January 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 25, 2020
• Last Update Submitted That Met QC Criteria: November 24, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: BTL-899THI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No