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

Carestream

Status: Completed

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

Treatments: Radiation: Radiation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01855425

6K0377

Details and patient eligibility

About

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

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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• Subjects not willing to consent, or consent is withdrawn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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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96 participants in 1 patient group

Investigational CBCT

Other group

Description:

Radiation

Treatment:

Radiation: Radiation