Examination of Circumferential Reduction

Not Applicable

Completed

• Conditions: Overweight or Obesity

• Registration Number: NCT04451824
• Lead Sponsor: Contour Research

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.

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2018-11-30
• Study Completion: 2018-12-31
• Status Verified: 2020-06
• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-26
• Last Update Submitted: 2020-06-26
• Study First Posted: 2020-06-30
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (3)

Gibson Clinic; 🇺🇸 Vista, California, United States

Barone Clinic; 🇺🇸 Savannah, Georgia, United States

Love Clinic; 🇺🇸 Kirkland, Washington, United States