Examination of Circumferential Reduction

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04451824
Study type	Interventional
Source	Contour Research
Contact
Status	Completed
Phase	N/A
Start date	September 1, 2018
Completion date	December 31, 2018

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.