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

Fat Burn Clinical Trial

Official title:

Simultaneous Application of High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Non-invasive Lipolysis and Improvement of Muscle Tone in Lateral Abdomen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05540080
• Other study ID #: BTL-899_CTUS700
• Status: Completed
• Phase: N/A
• Start date: June 10, 2022
• Est. completion date: October 11, 2023

Study information

• Verified date: April 2024
• Source: BTL Industries Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 11, 2023
• Est. primary completion date: January 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fat Burn

Intervention

Device:
• BTL-899
Treatment with applicators C4/C5 to the BTL-899 system.

Locations

Country	Name	City	State
United States	Chicago Cosmetic Surgery and Dermatology	Chicago	Illinois
United States	AboutSkin Research, LLC	Greenwood Village	Colorado
United States	Georgia Plastic & Reconstructive Surgery	Marietta	Georgia
United States	New Jersey Plastic Surgery (NJPS)	Montclair	New Jersey
United States	Laser & Skin Surgery Center of Northern California	Sacramento	California
United States	Integrated Aesthetics	Spring	Texas

Sponsors (1)

Lead Sponsor	Collaborator
BTL Industries Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of change in adipose and muscle layer thickness	The changes in muscles and adipose tissue of the treatment area between pre-treatment and post-treatment will be evaluated according to the MRI imaging and waist circumference measurements.; Using the obtained MRI images, changes in adipose and muscular tissues before and after the therapy sessions will be compared for every participant according to the study phase.; The circumference before and after the study therapy will be compared for each subject, according to the study phase. The circumference will be measured to identify any change in abdominal circumference related to changes in adipose tissue and muscle thickness.; When applicable, the statistical analysis will be conducted in Microsoft Excel spreadsheet software with a level of significance set to 5%.	4 months
Secondary	Subject Satisfaction	The 5-point Likert scale Subject Satisfaction Questionnaire will be used for an analysis of the subject's opinion of the therapy results, where the best possible answer would be "strongly agree" and the worst "strongly disagree".	4 months