Status:
COMPLETED
Comparing the Efficacy of a Dual-Frequency LLLT Device With a Sham Device as a Therapy for Adipose Tissue Loss
Lead Sponsor:
IR Technology, LLC
Conditions:
Obesity
Body Weight
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 plac...
Detailed Description
The trial was designed to prove the efficacy and safety of the invisa-RED Technology Elite Low-level Laser Therapy (LLLT) device. The trial compared results between two groups; the first group was tre...
Eligibility Criteria
Inclusion
- Any healthy individual.
Exclusion
- 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.
Key Trial Info
Start Date :
January 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2019
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03811093
Start Date
January 21 2019
End Date
February 9 2019
Last Update
September 15 2022
Active Locations (1)
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1
Cross Chiropractic Center
Hixson, Tennessee, United States, 37343