Clinical trial NCT04451824: Examination of Circumferential Reduction
Official title: Contour Research CL-100 Examination of Circumferential Reduction: A Review of Data Collected From Routine Use of the Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight or Obesity
Lead sponsor: Contour Research
Sponsor class: INDUSTRY
First posted: 2020-06-30
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Routine use of device
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Examination of Circumferential Reduction - Primary Objective
timeFrame: <1 hour
Secondary outcomes:
measure: Examination of Circumferential Reduction - Secondary Objective
timeFrame: <1 hour
Other outcomes:
Locations:
city: Vista
country: United States
facility: Gibson Clinic
state: California
city: Savannah
country: United States
facility: Barone Clinic
state: Georgia
city: Kirkland
country: United States
facility: Love Clinic
state: Washington
Study officials:
affiliation: Contour Research, LLC
name: Doug Dreier, BS
role: PRINCIPAL_INVESTIGATOR
References: