Examination of Circumferential Reduction

NCT04451824 | Completed FDA Device

• 1 other identifier: CL100 CR RetrX1
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 3

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.

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Examination of Circumferential Reduction - Secondary Objective

  <1 hour

Study Arms (1)

Intervention with Routine Use of Red Light

EXPERIMENTAL

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

Interventions

CL-100 DEVICE

Red Light LED device for circumferential reduction

Intervention with Routine Use of Red Light

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and Females ages 18 and above
• Generally good health

You may not qualify if:

• 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)

Sponsors & Collaborators

• Contour Research: lead

Study Sites (3)

Gibson Clinic

Vista, California, 92083, United States

Location

Barone Clinic

Savannah, Georgia, 31410, United States

Location

Love Clinic

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Doug Dreier, BS

  Contour Research, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Routine use of device

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 30, 2020
• Study Start: September 1, 2018
• Primary Completion: November 30, 2018
• Study Completion: December 31, 2018
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)