N/A
Completed N=96
Cone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose
CerebroSpinal Fluid (CSF) Leak · Chronic Otitis Media · Otospongiosis · Otosclerosis
Source: ClinicalTrials.gov NCT01855425 ↗
Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Percentage of Participants With >=3 Diagnostic Rating Using Radlex Scale — 92.63 percentage of participants
Summary
The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With >=3 Diagnostic Rating Using Radlex Scale |
92.63 | — |
Eligibility Criteria
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- Subjects not willing to consent, or consent is withdrawn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
Data sourced from ClinicalTrials.gov (NCT01855425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.