Effect of BTL-899 Device for Non-invasive Lipolysis on Human Upper Arms

This study will evaluate the clinical safety and the performance of the BTL-899 device during the treatment of upper arms.

Study Overview

• Status: Completed
• Conditions: Fat Burn
• Intervention / Treatment: Device: BTL-899

Detailed Description

The aim of the study is to confirm the efficacy and the safety of the treatment. The efficacy (reduction of excess adipose tissue) will be assessed via correct identification of pre-treatment and 3-months follow-up images by at least two out of three independent blinded evaluators. The fat reduction will be also measured by means of ultrasound. Comfort and satisfaction will be assessed via standard questionnaires.

Safety measures will include documentation of adverse events (AE) during and after the procedures.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1700
    • Dr Denkova Dermatology

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 site
• 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 in the area 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 the study participation.

Exclusion Criteria:

• Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
• Cardiovascular diseases
• Vascular diseases (such as chronic venous insufficiency, deep venous thrombosis, varicose veins, etc.)
• 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 in the arms
• Scars, open lesions, and wounds at the treatment area
• Basedow's disease
• Previous liposuction in the treatment area in the last six months
• Any other disease or condition at the investigator's discretion, e.g. dislocated shoulder or carpal tunnel syndrome than can pose danger to the patient or compromise the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-invasive lipolysis of the upper arms; The treatment administration phase consists of four (4) treatment visits, delivered 5- 10 - days apart. Each therapy session will last 30 minutes. Follow-ups visits at 1 month and 3 months after the final treatment will be held.	Device: BTL-899; Treatment with study device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Statistically significant reduction of fat thickness in the upper arms evaluated by photographs	To gather clinical evidence that the BTL-899 device is able to induce non-invasive lipolysis when used on upper arms. The primary efficacy outcome measure is a minimum 75% of the subjects' pre-treatment and 3-months follow-up images to be correctly identified by at least two of three independent blinded evaluators.	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire	Assessment the safety of the BTL-899 device when used for non-invasive lipolysis of the upper arms via questionnaires filled in by the participants following each therapy session. 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. The outcome will further be measured through the occurrence of adverse events or lack thereof.	7 months
Evaluation of the participants' satisfaction with the therapy evaluated via standard questionnaires	Evaluation of the participants' satisfaction with the therapy and the results. ● Minimum 80% of treated subjects to report satisfaction (level satisfied and higher) with the therapy.	5 months

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): August 2, 2021
• Study Completion (Actual): September 2, 2021

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Actual): September 9, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: BTL-899A

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
• product manufactured in and exported from the U.S.: No