Clinical Evaluation of the BTL-899 Device for Non-invasive Lipolysis on Human Fat Tissue

BTL

Status: Completed

Conditions: Improvement of Abdomen Appearance

Treatments: Device: BTL-899

Study type: Interventional

Funder types: Industry

Identifiers

NCT03923855

899-H1

Details and patient eligibility

About

The subjects will be enrolled and assigned to a single study group. They will be required to complete two treatment visits and come for a biopsy procedure.

Enrollment: 8 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age above 21 years and below 60 years
• Voluntarily signing of the informed consent form
• Women of child-bearing potential are required to use birth control measures during the whole duration of the study
• Eligibility to fat tissue biopsy at surgeon discretion, incl. at least 3-4 cm pinchable fat in the abdominal area
• Subjects willing and able to abstain from partaking in any 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

• Electronic implants (such as cardiac pacemakers, defibrillators and neurostimulators)
• Cardiovascular diseases
• 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
• Abdominal wall diastasis
• Unstable weight within the last 6 months (change in weight ± 3%)
• Previous body contouring treatments in the abdomen area in the last three months
• Any disease or condition contradicting the fat tissue biopsy at the surgeon discretion
• Any disease or condition that may compromise the histologic observation at the pathologist discretion

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

8 participants in 1 patient group

BTL-899 Therapy Arm

Experimental group

Treatment:

Device: BTL-899