Non-invasive Lipolysis and Improvement of Muscle Tone in Lateral Abdomen

BTL

Status: Completed

Conditions: Fat Burn

Treatments: Device: BTL-899

Study type: Interventional

Funder types: Industry

Identifiers

NCT05540080

BTL-899_CTUS700

Details and patient eligibility

About

This study will evaluate the clinical efficacy and performance of the BTL-899 device for changes in subcutaneous fat and muscle tissue in the lateral abdomen region (also referred to as flanks or "love handles"). The study is a prospective, multi-center, open-label, single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the subject device.

Full description

At the baseline visit, MRI imaging will be performed; the subject's weight and waist circumference will be recorded. Digital photographs of the treated area will be taken.

The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899 will be applied over the area of flanks. The device will induce visible muscle contractions along with heating of the subcutaneous fat. Each therapy session will last 30 minutes.

At the last therapy visit, the subject's weight and waist circumference will be recorded, and digital photographs of the treated area will be taken. In addition, subjects will receive Therapy Comfort and Subject Satisfaction Questionnaire to fill in.

Safety measures will include documentation of adverse events (AE), which will be assessed after each procedure and at all of the follow-up visits.

Enrollment: 46 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 22 years and older
• Voluntarily signed an 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 their regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation

Exclusion criteria

• Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
• Metal implants
• Drug pumps
• Malignant tumor
• Pulmonary insufficiency
• Injured or otherwise impaired muscles
• Cardiovascular diseases
• Disturbance of temperature or pain perception
• Hemorrhagic conditions
• Septic conditions and empyema
• Acute inflammations
• Systemic or local infection such as osteomyelitis and tuberculosis
• Contagious skin disease
• Elevated body temperature
• Pregnancy, postpartum period, nursing, and menstruation
• A metal-containing intrauterine device (IUD)
• Swollen or neoplastic tissues, space-occupying lesions or skin eruptions in the treatment area
• Graves' disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

46 participants in 1 patient group

Evaluation of change in adipose and muscle layer thickness

Experimental group

Description:

Evaluation of change in adipose and muscle layer thickness between pre-treatment and post-treatment based on MRI imaging and waist circumference measurements

Treatment:

Device: BTL-899