Overweight or Obesity
Conditions
Brief summary
The rationale for the selection of Outcome Measures is the compliance with FDA regulations as pertain to medical devices with a moderate level of risk of hazard leading to harm of the patient; firstly, the safety of the device in achieving the desired effect of its intended use when operated in the intended manner; and secondly, the effectiveness of the device in achieving its desired effect of its intended use in accordance with its proposed label and labeling. The rationale for the selection of the primary outcome measure is to satisfy the question of safety and effectiveness of the use of red-light exposure to reduce the circumference of overweight patients with a statistically significant Routine Use population size. Given that the Routine Use Data Analysis is open label and therefore not blinded, there is no need for a control group nor additional cohorts for varying levels of exposure and corresponding safety and/or effectiveness.
Detailed description
In the 1960s, the concept of using light energy for a variety of health maintenance goals and overcoming a number of dermatological conditions began in earnest to receive the attention of NASA researchers as a means of providing desired clinical outcomes to astronauts while in the confines of a space capsule over long periods of time. The research was well funded and supported by the U.S. government, and confirmed the value of light emitting diode (LED) low-level light therapy (LLLT), in particular red light from the 635nm frequency, for producing a variety of healthful effects within the dermis. The ability to achieve a reduction in the dimensions of exposed liposomes using red light is intended to be confirmed by analyzing the clinical data from a minimum of one hundred patients who were exposed to the 635 nm frequency for 30 minutes by use of the subject device (Contour Light) during routine use to confirm that the device is safe and effective for its intended application. Please see the following clinical articles, appended in section 10.
Interventions
DEVICECL-100
Red Light LED device for circumferential reduction
Sponsors
Contour Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Routine use of device
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Males and Females ages 18 and above * Generally good health
Exclusion criteria
* Pregnancy * Active cancer within the past year * Pacemaker * Diminished ability to void waste (liver and/or kidney function impairment) * Photosensitivity (generally and/or from medication)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Examination of Circumferential Reduction - Primary Objective | <1 hour | To confirm the proper use of the device induces a change in the circumference of the patients thighs, hips and waist, when exposed to the red light (635nm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Examination of Circumferential Reduction - Secondary Objective | <1 hour | To achieve a contour change, specifically a lessening of the protrusion of body fat, when exposed to the red light (635nm) |
Countries
United States
Outcome results
None listed