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

NCT05540080 | Completed FDA Device

• 1 other identifier: BTL-899_CTUS700
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 6

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.

Conditions

Fat Burn

Keywords

muscle toning; fat reduction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Subject Satisfaction

  4 months

Study Arms (1)

Evaluation of change in adipose and muscle layer thickness

EXPERIMENTAL

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

Device: BTL-899

Interventions

BTL-899 DEVICE

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

Evaluation of change in adipose and muscle layer thickness

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (6)

Laser & Skin Surgery Center of Northern California

Sacramento, California, 95816, United States

Location

AboutSkin Research, LLC

Greenwood Village, Colorado, 80111, United States

Location

Georgia Plastic & Reconstructive Surgery

Marietta, Georgia, 30008, United States

Location

Chicago Cosmetic Surgery and Dermatology

Chicago, Illinois, 60654, United States

Location

New Jersey Plastic Surgery (NJPS)

Montclair, New Jersey, 07042, United States

Location

Integrated Aesthetics

Spring, Texas, 77388, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 14, 2022
• Study Start: June 10, 2022
• Primary Completion: January 10, 2023
• Study Completion: October 11, 2023
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)