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

Otosclerosis Clinical Trial

— CBCT-ENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855425
• Other study ID #: 6K0377
• Status: Completed
• Phase: N/A
• Start date: September 21, 2012
• Est. completion date: August 9, 2013

Study information

• Verified date: July 2018
• Source: Carestream Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: August 9, 2013
• Est. primary completion date: August 9, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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• Subjects not willing to consent, or consent is withdrawn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

Related Conditions & MeSH terms

• CerebroSpinal Fluid (CSF) Leak
• Cholesteatoma
• Chronic Otitis Media
• Otitis Media
• Otosclerosis
• Otospongiosis
• Pulsatile Tinnitus
• Tinnitus

Intervention

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

Locations

Country	Name	City	State
Belgium	Sint-Augustinus Hospital	Antwerp
France	C.H.U Bicetre	Paris
United States	Johns Hopkins Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Carestream Health, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With >=3 Diagnostic Rating Using Radlex Scale	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