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NCT Number: NCT04451824

Examination of Circumferential Reduction

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.

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Key information

Conditions

Overweight or Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gibson Clinic, Vista, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CL-100

Device

Red Light LED device for circumferential reduction

Primary outcomes

  1. Examination of Circumferential Reduction - Primary Objective

    Time frame: <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 outcomes

  1. Examination of Circumferential Reduction - Secondary Objective

    Time frame: <1 hour

    To achieve a contour change, specifically a lessening of the protrusion of body fat, when exposed to the red light (635nm)

Sponsors and collaborators

Lead sponsor

Contour Research

Industry

Registry information

Official study title

Contour Research CL-100 Examination of Circumferential Reduction: A Review of Data Collected From Routine Use of the Device

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 30, 2020
Registry last updated
Jun 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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