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

NCT ID: NCT04643275

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2021-09-02

Brief Summary

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

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.

Conditions

Fat Burn

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

BTL-899

Intervention Type: DEVICE

Treatment with study device.

Interventions

BTL-899

Treatment with study device.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 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

Locations

Dr Denkova Dermatology

Sofia, , Bulgaria

Countries

Bulgaria

Other Identifiers

BTL-899A

Identifier Type: -

Identifier Source: org_study_id