Fat Burn Clinical Trial
Official title:
Histological Evaluation of BTL-899 Device´s Effect on Fat Tissue
Verified date | August 2022 |
Source | BTL Industries Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the safety and performance of the BTL-899 device for non-invasive treatment of subcutaneous fat. The changes in the fat tissue related to the activity of caspase-3 will be assessed histologically. The study is a prospective single-center single-blinded two-arm study. The subjects will be enrolled and assigned into two study groups; Group A which will receive active treatment and Group B which receives sham treatment and will serve as a control to verify the treatment outcomes. Subjects will be required to complete only one (1) treatment visit and three (3) follow-up visits (at 8 hours, 24 hours and 7 days post treatment). All of the study subjects will receive the treatment (either active or sham) with the subject device. At the baseline visit, health status will be assessed. Inclusion and exclusion criteria will be verified and informed consent will be signed. Punch biopsies from the treated abdominal area will be taken to examine the changes related to caspase-3 activity.
Status | Completed |
Enrollment | 7 |
Est. completion date | August 11, 2022 |
Est. primary completion date | April 27, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Age > 21 years - 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. - Willingness to abstain from partaking in any treatments other than the study procedure - Willingness to comply with study instructions, to return to the clinic for the required visits and to undergo punch biopsies in the abdominal area. Exclusion Criteria: - Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators) - Metal implants in the treated area - Drug pumps - Malignant tumor - Pulmonary insufficiency - Injured or otherwise impaired muscles in the treated area - Cardiovascular diseases - Disturbance of temperature or pain perception - Hemorrhagic conditions - Septic conditions and empyema - Acute inflammations in the treated area - Systemic or local infection such as osteomyelitis and tuberculosis - Contagious skin disease - Elevated body temperature - Application during pregnancy, postpartum period, nursing, and menstruation - Graves' disease - Skin related autoimmune diseases that may contradict the biopsy - Poor healing and unhealed wounds in the treatment area - Any disease or condition contradicting the skin tissue biopsy - Any disease or condition that may compromise the histologic observation at the pathologist discretion |
Country | Name | City | State |
---|---|---|---|
United States | Skin Laser and Surgery Specialist, a Division of Schweiger Dermatology | Hackensack | New Jersey |
Lead Sponsor | Collaborator |
---|---|
BTL Industries Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Increased caspase-3 activity | Biopsy samples of the abdominal fat tissue will be processed for histological evaluation by a certified laboratory. Conventional staining will be used to determine the changes in the fat tissue related to the increase in caspase-3 activity, which is associated with elevated levels of fat tissue apoptosis, and to examine other morphological changes of treated tissue, in all collected samples. Post-treatment findings will be compared to the baseline. The results of both study groups will be compared as well. | 1 month | |
Secondary | Safety assessment | Occurrence of adverse events | 1 month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04599257 -
Fat Reduction and Muscle Toning of Thighs
|
N/A | |
Completed |
NCT05580263 -
Different Order of Concurrent Training on Improving Visceral Adipose Tissue and Insulin Resistance.
|
N/A | |
Completed |
NCT04643275 -
Effect of BTL-899 Device for Non-invasive Lipolysis on Human Upper Arms
|
N/A | |
Completed |
NCT05975489 -
Genetics in the Effect of Caffeine on Fat Oxidation
|
N/A | |
Completed |
NCT04621019 -
BTL-785F Device for Non-invasive Lipolysis and Circumference Reduction of the Abdomen
|
N/A | |
Completed |
NCT04696614 -
Testing the Effect of Exercise Intervention Using a SMART Design.
|
N/A | |
Completed |
NCT04455009 -
Acute Effects of Fitness Drink Formulas on Energy Expenditure and Fat Metabolism
|
N/A | |
Completed |
NCT05260164 -
Effect of BTL-899 Device for Non-invasive Lipolysis on Human Flanks
|
N/A | |
Recruiting |
NCT05261373 -
Efficacy of a Nutritional Education Strategy and Physical Exercise on the Gut Microbiota in Type 2 Diabetics
|
N/A | |
Recruiting |
NCT04043182 -
EFFECTIVENESS OF ULTRASOUND FOR LOCAL FAT TREATMENT
|
N/A | |
Completed |
NCT04587804 -
Abdomen - Fat Reduction and Muscle Toning
|
N/A | |
Completed |
NCT05540080 -
Non-invasive Lipolysis and Improvement of Muscle Tone in Lateral Abdomen
|
N/A | |
Completed |
NCT04587986 -
rPMS and Radiofrequency for Abdominal Toning and Reduction of Subcutaneous Fat
|
N/A | |
Active, not recruiting |
NCT06274177 -
Evaluation of the BTL-785F Device for Submental Fat Reduction and Neck Rejuvenation
|
N/A | |
Completed |
NCT06282172 -
Histological Evaluation of BTL-785F Device's Effect on Submental Subcutaneous Adipose Tissue
|
N/A | |
Not yet recruiting |
NCT03357601 -
High Intensity Interval Training vs Moderate Continuous Endurance Exercise Training on Program Adherence
|
N/A | |
Completed |
NCT05215275 -
Comparison of Different Exercise Trainings on Heart Rate Variability
|
N/A | |
Completed |
NCT03811093 -
Comparing the Efficacy of a Dual-Frequency LLLT Device With a Sham Device as a Therapy for Adipose Tissue Loss
|
N/A | |
Active, not recruiting |
NCT06333496 -
Effect of a Glucagon Like Peptide 1 (GLP1) Booster in Healthy Humans
|
N/A | |
Not yet recruiting |
NCT06219850 -
Physical Exercise, Diet, and Health in People With Type 2 Diabetes: Longitudinal Design of the EDUGUTION Study
|