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

Not Applicable

Completed

• Conditions: CerebroSpinal Fluid (CSF) Leak; Otosclerosis; Chronic Otitis Media; Pulsatile Tinnitus; Otospongiosis; Cholesteatoma
• Interventions: Radiation: Radiation

• Registration Number: NCT01855425
• Lead Sponsor: Carestream Health, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2012-09-21
• Study First Submitted: 2013-05-06
• Study First Submitted QC: 2013-05-14
• Study First Posted: 2013-05-16
• Primary Completion: 2013-08-09
• Study Completion: 2013-08-09
• Results First Submitted: 2017-07-12
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-03
• Last Update Submitted: 2018-07-31
• Results First Posted: 2018-08-01
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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• Subjects not willing to consent, or consent is withdrawn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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigational CBCT	Radiation	Radiation

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With >=3 Diagnostic Rating Using Radlex Scale	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.

Trial Locations

Locations (3)

Johns Hopkins Medical Center; 🇺🇸 Baltimore, Maryland, United States

C.H.U Bicetre; 🇫🇷 Paris, France

Sint-Augustinus Hospital; 🇧🇪 Antwerp, Belgium