Clinical trial NCT05540080: Non-invasive Lipolysis and Improvement of Muscle Tone in Lateral Abdomen
Official title: Simultaneous Application of High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Non-invasive Lipolysis and Improvement of Muscle Tone in Lateral Abdomen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fat Burn
Keywords: muscle toning
fat reduction
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2022-09-14
Enrollment: 46
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of change in adipose and muscle layer thickness
timeFrame: 4 months
Secondary outcomes:
measure: Subject Satisfaction
timeFrame: 4 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Laser & Skin Surgery Center of Northern California
state: California
city: Greenwood Village
country: United States
facility: AboutSkin Research, LLC
state: Colorado
city: Marietta
country: United States
facility: Georgia Plastic & Reconstructive Surgery
state: Georgia
city: Chicago
country: United States
facility: Chicago Cosmetic Surgery and Dermatology
state: Illinois
city: Montclair
country: United States
facility: New Jersey Plastic Surgery (NJPS)
state: New Jersey
city: Spring
country: United States
facility: Integrated Aesthetics
state: Texas
Study officials:
References: