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Completed

NCT Number: NCT01855425

Cone Beam CT 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.

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Key information

Conditions

CerebroSpinal Fluid (CSF) Leak Cholesteatoma Chronic Otitis Media Ear Diseases Hearing Disorders Keratosis Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Otosclerosis Otospongiosis Pathological Conditions, Signs and Symptoms Pulsatile Tinnitus Sensation Disorders Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Tinnitus

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sint-Augustinus Hospital, Antwerp, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Subjects not willing to consent, or consent is withdrawn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

Treatment and study plan

Radiation

Radiation

Subjects to receive standard of care CT scan and additional Cone Beam CT scan.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Carestream Health, Inc.

Industry

Registry information

Official study title

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

Acronym: CBCT-ENT

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 16, 2013
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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