Cone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose (CBCT-ENT)

July 31, 2018 updated by: Carestream Health, Inc.

Cone Beam CT (CS 9300) for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose

The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT. It proposes a direct comparison of diagnostic image quality between the CS 9300 and CT for the ability to view and confirm ENT disorders.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium
        • Sint-Augustinus Hospital
  • France
      • Paris, France
        • C.H.U Bicetre
  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject must be 18-80 years of age
  • Subjects has provided informed consent
  • Subjects must present with symptoms and/or pathology of the sinus or temporal bone region.
  • Subject scheduled for additional radiological follow-up and/or endoscopy/surgery.
  • CBCT exam performed within a maximum of 2 days of the conventional CT.

Exclusion Criteria:

  • Subjects under the age of 18 years, or over the age of 80 years
  • Unable to collect all required case information
  • Subjects not willing to consent, or consent is withdrawn
  • Women in pregnancy or suspected of being pregnant confirmed by pregnancy test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Investigational CBCT
Radiation
Radiation: Radiation
Subjects to receive standard of care CT scan and additional Cone Beam CT scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With >=3 Diagnostic Rating Using Radlex Scale
Time Frame: 11 months

Percentage of Participants with >=3 Diagnostic Rating Using Radlex Scale. Five radiologists participated in reader study using Radlex scale below to analyze and rate participant images. They determined if they could make a medical diagnosis for ENT patients.

Used Radlex Scale - 1-Non-diagnostic, Unacceptable for diagnostic purposes. 2-Limited Acceptable, with some technical defect. 3-Diagnostic, Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary, Good most adequate for diagnostic purposes.
11 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carestream Health, Inc.

Investigators

  • Principal Investigator: Douglas Reh, MD, Johns Hopkins Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2012

Primary Completion (Actual)

August 9, 2013

Study Completion (Actual)

August 9, 2013

Study Registration Dates

First Submitted

May 6, 2013

First Submitted That Met QC Criteria

May 14, 2013

First Posted (Estimate)

May 16, 2013

Study Record Updates

Last Update Posted (Actual)

August 28, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6K0377

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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