Examination of Circumferential Reduction

NCT ID: NCT04451824

Last Updated: 2020-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2018-12-31

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.

Conditions

Overweight or Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CL-100

Intervention Type: DEVICE

Red Light LED device for circumferential reduction

Interventions

CL-100

Red Light LED device for circumferential reduction

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Contour Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Doug Dreier, BS

Role: PRINCIPAL_INVESTIGATOR

Contour Research, LLC

Locations

Gibson Clinic

Vista, California, United States

Barone Clinic

Savannah, Georgia, United States

Love Clinic

Kirkland, Washington, United States

Countries

United States

Other Identifiers

CL100 CR RetrX1

Identifier Type: -

Identifier Source: org_study_id