Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen

BTL

Status: Completed

Conditions: Improvement of Abdomen Appearance

Treatments: Device: BTL-899

Study type: Interventional

Funder types: Industry

Identifiers

NCT03270150

BTL-899L

Details and patient eligibility

About

The study is a prospective open-label single-arm study that includes three treatment procedures and four follow-up visits.

Full description

This study will evaluate the clinical efficacy and safety of the BTL-899 device for non-invasive lipolysis and circumference reduction of abdomen. The study is a prospective open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will complete three (3) treatment visits and will be invited to four (4) follow-up visits 1, 2, 3 and 6-months after the final treatment. 6-months follow-up visit is the optional one.

Enrollment: 40 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥ 21 years
• Voluntarily signed informed consent form
• BMI ≤ 35 kg/m2
• Women of child-bearing potential are required to use birth control measures during the whole duration of the study
• Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring 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

• Cardiac pacemakers
• Cardiovascular diseases
• Implanted defibrillators, implanted neurostimulators
• Electronic implants
• 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
• Contageous 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
• Abdominal wall diastasis
• Unstable weight within the last 6 months
• Previous body contouring treatments in the abdomen area in the last three months

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

BTL-899 Therapy Arm

Experimental group

Description:

BTL-899 therapy, 3 therapies

Treatment:

Device: BTL-899