Obesity Clinical Trial
Official title:
Comparing the Efficacy of a Dual-Frequency Laser-Emitting Device, the "Invisared-RED Elite", With a Sham Device as Therapy for the Loss of Adipose Tissue (Body Fat) and Aesthetics in Overweight Individuals
Verified date | August 2022 |
Source | IR Technology, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The trial was designed to provide empirical evidence with which to compare the efficacy and safety of the invisa-RED Technology Elite Low-level Laser Therapy (LLLT) device with a sham device as a placebo, when both are used in the treatment of individuals to reduce body fat and improve body aesthetics. At the conclusion of the trial; the change in body fat percentage, the change in total body fat in pounds, and total inches lost of the two groups were statistically analyzed to determine the efficacy of the invisa-RED Technology Elite when used for body fat (adipose tissue) loss and/or aesthetics therapy.
Status | Completed |
Enrollment | 39 |
Est. completion date | February 9, 2019 |
Est. primary completion date | February 9, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Any healthy individual. Exclusion Criteria: - If you are pregnant, trying to get pregnant or nursing laser light therapy should be received only after the end of these conditions. There is no evidence of harm to a an unborn baby however there have been no safety tests either, so for medical legal reasons we recommend never treating areas directly over a developing child. - Individuals with hypertension, light sensitive epilepsy, cancer, heart disease, infectious skin disease, and severe varicose veins should not use this device. - People suffering from infectious and acute disease such as a fever should not use this device. - People who have hemorrhagic disease, vascular ruptures, skin inflammation, or any disease of the skin should not use this device. - People who have immune system dysfunction such as Leukemia, Hemophilia, etc., and light sensitive persons should not use this device. - Individuals with a history of melanoma, raised moles, suspicious lesions, keloid scar formation, or healing problems should not undergo laser light therapy. - Individuals with active infections, open lesions, hives, herpetic lesions, cold sores, or tattoos and permanent make-up in the area of treatment should not undergo laser light therapy. - People who have used isotretinoin (commonly known as Accutane), tetracycline, St. John's Wort, or any photo sensitizing drugs in the last year should not undergo laser light therapy. - Individuals with autoimmune diseases such as Lupus, Scleroderma, or Vitiligo should not undergo laser light therapy. - Individuals who have pacemakers or other electro-stimulation devices surgically implanted should not undergo laser light therapy. - Any insulin dependent individual should consult their physician before undergoing laser light therapy. - All individuals considered "vulnerable" such as children, pregnant women, nursing home residents or other institutionalized persons, students, employees, fetuses, prisoners, and persons with decisional incapacity. |
Country | Name | City | State |
---|---|---|---|
United States | Cross Chiropractic Center | Hixson | Tennessee |
Lead Sponsor | Collaborator |
---|---|
IR Technology, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Body Fat Percentage | Measured change in body fat as a percentage of total weight. | In order to determine change over time, body fat as a percentage of body weight will be measured before any treatment at first therapy session and measured again for comparison at the end of three weeks therapy. | |
Primary | Change in Body Circumference Measurements | The prescribed body circumference measurements of the chest, right arm, upper-waist, mid-waist, hips, and right thigh are summed for each participant and recorded. | In order to determine change over time, the prescribed body measurements will be summed for each participant and recorded before any treatment at first therapy session and recorded again for comparison at the end of three weeks therapy. | |
Primary | Change in Weight of Body Fat | The percentage of body fat for each participant was measured using Bioelectrical Impedance Analysis (BIA). That percentage is then multiplied by the total body weight of the participant in order to calculate the weight in pounds of the participants body fat. | In order to determine change over time, each participants body fat weight will be calculated before any treatment at the first therapy session and calculated again to determine if there exists any change at the end of three weeks therapy. |
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