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Examination of Circumferential Reduction

NCT04451824 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2020-06-30

No results posted yet for this study

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

Interventions

DEVICE

CL-100

Red Light LED device for circumferential reduction

Sponsors & Collaborators

  • Contour Research

    lead INDUSTRY

Principal Investigators

  • Doug Dreier, BS · Contour Research, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2018-11-30
Completion
2018-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04451824 on ClinicalTrials.gov