N/A N=96 Diagnostic

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

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

Bottom Line

View on ClinicalTrials.gov: NCT01855425 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2018

Primary outcome: Primary: Percentage of Participants With >=3 Diagnostic Rating Using Radlex Scale — 92.63 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Radiation (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Carestream Health, Inc.
Primary completion: Aug 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With >=3 Diagnostic Rating Using Radlex Scale	92.63	—

Summary

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

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Subjects not willing to consent, or consent is withdrawn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

View full record on ClinicalTrials.gov →

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.