CerebroSpinal Fluid (CSF) Leak, Cholesteatoma, Chronic Otitis Media, Otosclerosis, Otospongiosis, Pulsatile Tinnitus
Conditions
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 for the ability to view and confirm ENT disorders.
Interventions
RADIATIONRadiation
Subjects to receive standard of care CT scan and additional Cone Beam CT scan.
Sponsors
Carestream Health, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Predicate CT Scan and Investigational Cone Beam Scan
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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the age of 80 years * Unable to collect all required case information * Subjects not willing to consent, or consent is withdrawn * Women in pregnancy or suspected of being pregnant confirmed by pregnancy test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With >=3 Diagnostic Rating Using Radlex Scale | 11 months | 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. |
Countries
Belgium, France, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Investigational CBCT Investigator orders CT as part of Standard of Care. Subject consents to be in study and they are also given a Cone Beam CT.
Radiation: Subjects to receive standard of care CT scan and additional Cone Beam CT scan. | 96 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 20 |
Baseline characteristics
| Characteristic | Investigational CBCT |
|---|---|
| Age, Customized > 18 years - < 80 years | 96 participants |
| Region of Enrollment Belgium | 32 participants |
| Region of Enrollment France | 45 participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | NA Participants |
| Sex: Female, Male Male | NA Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 96 |
| other Total, other adverse events | 0 / 96 |
| serious Total, serious adverse events | 0 / 96 |
Outcome results
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.
Time frame: 11 months
Population: 96 participants were imaged for this study, but only 76 participant image pairs were analyzed in the reader study. 20 participant image pairs were disqualified by the physicians due movement/unclear image quality.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational CBCT | Percentage of Participants With >=3 Diagnostic Rating Using Radlex Scale | 92.63 percentage of participants | Standard Deviation 4.9 |