Fat Burn Clinical Trial
Official title:
Efficacy of Simultaneous Application of Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) and Radiofrequency for Abdominal Toning and Reduction of Subcutaneous Fat: Single-Blind Randomized Sham-Controlled Trial
Verified date | March 2021 |
Source | BTL Industries Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the clinical efficacy and safety of a simultaneous treatment by high power magnet and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. The study is a prospective multi-center single-blinded sham-controlled study. The subjects will be enrolled and assigned into two study groups; active and sham group. Subjects of both groups will be required to complete three (3) treatment visits and two to three follow-up visits.
Status | Completed |
Enrollment | 67 |
Est. completion date | March 16, 2021 |
Est. primary completion date | June 16, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Voluntarily signed 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 her 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 - Intrauterine device (IUD) - Swollen or neoplastic tissues, space-occupying lesions or skin eruptions in the treatment area - Basedow's disease |
Country | Name | City | State |
---|---|---|---|
United States | Maryland Laser Skin and Vein Institute | Hunt Valley | Maryland |
United States | JUVA Skin & Laser Center | New York | New York |
United States | Julene B. Samuels | River Bluff | Kentucky |
Lead Sponsor | Collaborator |
---|---|
BTL Industries Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in fat and muscle thickness in the abdominal area measured via ultrasound. | To gather clinical evidence on the effectiveness of the combined treatment for abdominal toning and subcutaneous fat reduction through changes in abdominal tissues, measured via ultrasound and comparison of active and sham groups. The changes will be considered statistically significant where p-value <0.05. | 7 months | |
Secondary | Patient's satisfaction with study treatment measured via questionnaires | To determine the patient's satisfaction with study treatment for non-invasive aesthetic improvement of the abdomen. The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant's satisfaction with the therapy outcome. Subject satisfaction will be assessed after the last therapy visit and during the follow-up visits. | 7 months | |
Secondary | Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire | The outcome will further be measured through the occurrence of adverse events or lack thereof. On Numerical Analog Scale (0-10), where 0 represents 'no pain' and 10 represents 'worst possible pain' select the level of pain experienced during the treatment. | 7 months |
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 |
NCT05139745 -
Histological Evaluation of BTL-899 Device´s Effect on Fat Tissue
|
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 | |
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
|