Examination of Circumferential Reduction
Completed · Not applicable
Conditions studied: Overweight or Obesity
In brief
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.
Key facts
- Study ID
- NCT04451824
- Run by
- Contour Research
- People needed
- 118
- Starts
- 2018-09-01
- Expected to finish
- 2018-12-31
- Last updated by the study team
- 2020-06-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Males and Females ages 18 and above
- Generally good health
You may not qualify if…
- 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)
Where it is running
- Gibson Clinic — Vista, California, United States
- Barone Clinic — Savannah, Georgia, United States
- Love Clinic — Kirkland, Washington, United States
Full record on ClinicalTrials.gov
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