Examination of Circumferential Reduction

Overweight or Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04451824
• Other study ID #: CL100 CR RetrX1
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2020
• Source: Contour Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 31, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Overweight
• Overweight or Obesity

Intervention

Device:
• CL-100
Red Light LED device for circumferential reduction

Locations

Country	Name	City	State
United States	Love Clinic	Kirkland	Washington
United States	Barone Clinic	Savannah	Georgia
United States	Gibson Clinic	Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Contour Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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