Non-invasive Lipolysis on Human Thighs and Saddlebags

BTL

Status: Completed

Conditions: Adipose Tissue Reduction

Treatments: Device: BTL-899

Study type: Interventional

Funder types: Industry

Identifiers

NCT04221646

BTL-899THI

Details and patient eligibility

About

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

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Thighs circumference reduction

Experimental group

Description:

The subjects will be enrolled and treated once per week. Both legs will be treated consecutively. The therapy will be applied simultaneously.

Treatment:

Device: BTL-899

Saddlebags fat thickness reduction

Experimental group

Description:

The subjects will be enrolled and treated once per week. Both legs will be treated consecutively. The therapy will be applied consecutively too.

Treatment:

Device: BTL-899