Examination of Circumferential Reduction

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight or Obesity
• Intervention / Treatment: Device: CL-100

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 Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Vista, California, United States, 92083
      • Gibson Clinic
  • Georgia
    • Savannah, Georgia, United States, 31410
      • Barone Clinic
  • Washington
    • Kirkland, Washington, United States, 98034
      • Love Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention with Routine Use of Red Light; Routine Use of red light (635nm) for 30 minutes on patients is to be observed in relation to its effect(s) in achieving circumferential reduction of the thighs, hips and waist of the patient, and a contour reduction of any protrusion of fat.	Device: CL-100; Red Light LED device for circumferential reduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examination of Circumferential Reduction - Primary Objective	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)	<1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examination of Circumferential Reduction - Secondary Objective	To achieve a contour change, specifically a lessening of the protrusion of body fat, when exposed to the red light (635nm)	<1 hour

Collaborators and Investigators

• Sponsor: Contour Research
• Investigators: Principal Investigator: Doug Dreier, BS, Contour Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: CL100 CR RetrX1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share the individual participant data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No