Status:
COMPLETED
Cone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose
Lead Sponsor:
Carestream Health, Inc.
Conditions:
CerebroSpinal Fluid (CSF) Leak
Chronic Otitis Media
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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- Subjects not willing to consent, or consent is withdrawn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
Key Trial Info
Start Date :
September 21 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2013
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01855425
Start Date
September 21 2012
End Date
August 9 2013
Last Update
August 28 2018
Active Locations (3)
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1
Johns Hopkins Medical Center
Baltimore, Maryland, United States, 21287
2
Sint-Augustinus Hospital
Antwerp, Belgium
3
C.H.U Bicetre
Paris, France