- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05540080
Non-invasive Lipolysis and Improvement of Muscle Tone in Lateral Abdomen
Simultaneous Application of High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Non-invasive Lipolysis and Improvement of Muscle Tone in Lateral Abdomen
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Sacramento, California, United States, 95816
- Laser & Skin Surgery Center of Northern California
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Colorado
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Greenwood Village, Colorado, United States, 80111
- AboutSkin Research, LLC
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Georgia
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Marietta, Georgia, United States, 30008
- Georgia Plastic & Reconstructive Surgery
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Illinois
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Chicago, Illinois, United States, 60654
- Chicago Cosmetic Surgery and Dermatology
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New Jersey
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Montclair, New Jersey, United States, 07042
- New Jersey Plastic Surgery (NJPS)
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Texas
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Spring, Texas, United States, 77388
- Integrated Aesthetics
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Evaluation of change in adipose and muscle layer thickness
Evaluation of change in adipose and muscle layer thickness between pre-treatment and post-treatment based on MRI imaging and waist circumference measurements
|
Treatment with applicators C4/C5 to the BTL-899 system.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of change in adipose and muscle layer thickness
Time Frame: 4 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject Satisfaction
Time Frame: 4 months
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BTL-899_CTUS700
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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