Reader Study to Demonstrate That Use of ClearRead Confirm is Superior to the Use Standard AP/PA X-ray Image

NCT ID: NCT01655329

Last Updated: 2014-07-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-02-28

Brief Summary

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This is a study to determine whether or not a new type of software is, or is not, of benefit. The software, ClearRead Confirm, is designed to enhance the ability of radiologists to detect tubes, lines and wires that may be placed within a patients chest. These types of devices are commonly used for very sick patients in intensive care units and are also used following surgery and in the treatment of cancer. This study will test radiologist's detection of the tips of these devices comparing the results with standard chest radiographs and the the modified chest radiographs. The primary interest is in the time used to interpret the radiograph. We will determine if there is any change in accuracy of detection.

Detailed Description

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Primary hypothesis: the amount of time used for the interpretation of these radiographs will not change. (null hypothesis)

Secondary hypothesis: there will be no change in the accuracy of the detection of the tips of venous catheters and tubes transiting the esophagus. (null hypothesis)

Conditions

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Catheters, With or Without Malposition Image Interpretation, Computer Assisted

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard chest radiographs

The radiologists will be viewing two groups of chest images. The first group are standard chest radiographs.

No interventions assigned to this group

Modified chest radiographs

This group of chest radiographs will be presented with the modified image. The modified image is intended to increase the visibility of tubes, lines and wires on chest radiographs

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* For the radiologists, they must in in active practice of community radiology (non-university sites).
* For the cases, they must be patients who have a tube, line, or wire in their chest. A small number of completely normal bedside chest radiographs will be included.

Exclusion Criteria

* For radiologists: Not in active practice. Working in a university hospital.
* For cases: children. Do not meet image quality criteria.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Riverain Technologies

INDUSTRY

Sponsor Role collaborator

Georgetown University

OTHER

Sponsor Role lead

Responsible Party

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Matthew T. Freedman, MD

Associate Professor Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthew T Freedman, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Shih-Chung Ben Lo, Ph.D.

Role: STUDY_DIRECTOR

Georgetown University

Locations

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Georgetown University Medical Center, Suite 603, 2115 Wisconsin Ave

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

Other Identifiers

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MF 2012-1

Identifier Type: -

Identifier Source: org_study_id

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