Examination of Circumferential Reduction

• ClinicalTrials.gov Identifier: NCT04451824
• Recruitment Status: Completed
• First Posted: June 30, 2020
• Last Update Posted: June 30, 2020
• Sponsor: Contour Research
• Information provided by (Responsible Party): Contour Research

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Overweight or Obesity	Device: CL-100	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 118 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Routine use of device
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Contour Research CL-100 Examination of Circumferential Reduction: A Review of Data Collected From Routine Use of the Device
• Actual Study Start Date: September 1, 2018
• Actual Primary Completion Date: November 30, 2018
• Actual Study Completion Date: December 31, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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)

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Locations

United States, California

Gibson Clinic

Vista, California, United States, 92083

United States, Georgia

Barone Clinic

Savannah, Georgia, United States, 31410

United States, Washington

Love Clinic

Kirkland, Washington, United States, 98034

Sponsors and Collaborators

Contour Research

Investigators

• Principal Investigator: Doug Dreier, BS; Contour Research, LLC

More Information

• Responsible Party: Contour Research
• ClinicalTrials.gov Identifier: NCT04451824
• Other Study ID Numbers: CL100 CR RetrX1
• First Posted: June 30, 2020
• Last Update Posted: June 30, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: There is no plan to share the individual participant data with other researchers.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Overweight; Overnutrition; Nutrition Disorders; Body Weight