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The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational CBCT | Other | Radiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation | Radiation | Subjects to receive standard of care CT scan and additional Cone Beam CT scan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 11 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Reh, MD | Johns Hopkins Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Medical Center | Baltimore | Maryland | 21287 | United States | ||
| Sint-Augustinus Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational CBCT | Investigator orders Medical 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of participants | 11 months |
|
11 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Pate, RN, MS, RAC | Carestream Health, Inc. | 585-627-6557 | susan.pate@carestream.com |
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| ID | Term |
|---|---|
| D010040 | Otosclerosis |
| D014012 | Tinnitus |
| D002781 | Cholesteatoma |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006311 | Hearing Disorders |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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Predicate CT Scan and Investigational Cone Beam Scan
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| Antwerp |
| Belgium |
| C.H.U Bicetre | Paris | France |
| participants |
|
| Sex: Female, Male | gender data was not collected | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Investigational CBCT images
|
|
| 0 |
| 96 |
| 0 |
| 96 |
| 0 |
| 96 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |