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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01655329
Recruitment Status : Completed
First Posted : August 1, 2012
Results First Posted : July 10, 2014
Last Update Posted : July 10, 2014
Riverain Technologies
Information provided by (Responsible Party):
Matthew T. Freedman, MD, Georgetown University

Brief Summary:
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.

Condition or disease
Catheters, With or Without Malposition Image Interpretation, Computer Assisted

Detailed Description:

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)

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Reader Study to Demonstrate That Use of ClearRead Confirm is Superior to the Use Standard AP/PA X-ray Image. AP Stands for Antero-Posterior. PA Stands for Postero-anterior.
Study Start Date : August 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays
Drug Information available for: X-Rays
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Time for Completion of Tasks [ Time Frame: 8 hours ]
    Time for completion of tasks of identifying the tips of tubes, lines, and wires. Outlying values are excluded from the calculation of the mean values and standard errors. Outlying values were defined as those more than three standard deviations from the mean time.

  2. Accuracy in Detecting the Tips of Tubes, Lines, and Wires. [ Time Frame: 8 hours ]
    Measurement of accuracy in determining the location of the tips of nasogastric tubes (NG) (various types of nasogastric tubes combined) and of the tips of venous catheters (various types of venous catheters combined), compared to the determination of the expert panel. Measure is the distance from the median location determined by five experts in chest radiology.

Other Outcome Measures:
  1. Likert-Like [ Time Frame: 10 minutes ]
    Following the viewing of the test radiographs, the radiologists were asked a series of questions of overall preference. On this scale, 1 indicates strong disagreement, 5 indicates strongly agree. Ten statements were used. Note that a low value for the standard image is equivalent to a high value for the modified image.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
There are two populations: the radiologists and the cases they will review. For cases, these are sequential cases selected by database search using defined search criteria.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01655329

United States, District of Columbia
Georgetown University Medical Center, Suite 603, 2115 Wisconsin Ave
Washington,, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Riverain Technologies
Principal Investigator: Matthew T Freedman, MD, MBA Georgetown University
Study Director: Shih-Chung Ben Lo, Ph.D. Georgetown University

Responsible Party: Matthew T. Freedman, MD, Associate Professor Oncology, Georgetown University Identifier: NCT01655329     History of Changes
Other Study ID Numbers: MF 2012-1
First Posted: August 1, 2012    Key Record Dates
Results First Posted: July 10, 2014
Last Update Posted: July 10, 2014
Last Verified: June 2014

Keywords provided by Matthew T. Freedman, MD, Georgetown University:
Image Processing