Sinonasal Pathologies Clinical Trial
— COSINUSOfficial title:
Assessment of the Morphological Concordance Between CT and Cone Beam in Sinus Imagery
This study compares the morphological concordance between CT (computed tomography) and cone beam in sinus on 26 validated items. CT and cone beam is performed on each patient. Performances of these two imagery technics seem to be closed. Nevertheless, the exposure of the ionizing radiations is lower with the cone beam.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | February 2016 |
| Est. primary completion date | February 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - man or woman older than 18 years old - patient affected by sinonasal pathology : who show one or more of the following functional sign : anosmia, pain with sinusal origin (frontal headache, lower-orbital throbbing pain increased in anteflexion, chronic unexplained headache), nasal blockage, runny nose, epistaxis requiring the realisation of a sinus imagery overview. Exclusion Criteria: - Deprivation of liberty by administrative or legal decision - patients under 18 years old - Patients in emergency |
Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | VERGEZ | Toulouse |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Toulouse |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | intraclass correlation coefficient | Assessment of the morphological concordance between the CT and the Cone Beam in the sinus imagery with 26 validated items. | 1 day | No |
| Secondary | morphological concordance between cone beam and CT | Assessment of the morphological concordance between the CT and the Cone Beam in the sinus imagery with these 26 items assessed separately | 1 day | No |
| Secondary | reproductibility INTER-OBSERVER | The reproducibility of the measurement between the two neuroradiologists will be assessed by intraclass correlation coefficient, based on 26 benchmarks of primary endpoint. Similarly inter-observer reproducibility will be assessed for the 36 specific criteria | 1 day | No |
| Secondary | dosimetry | Assessment of the dosimetry CT/ Cone Beam | 1 day | No |
| Secondary | Diagnosis concordance radio-endoscopic and radio-surgical | Radio-endoscopic surgical concordance and radio will be estimated by calculating the proportion of concordant diagnoses between the radiological evaluation and cone beam scanner and endoscopic evaluation obtained at the first nasal endoscopy and radiological evaluation between the scanner and cone beam and intraoperative assessment in case of surgery. The investigators then compare the radio-endoscopic surgical concordance and radio and the cone beam scanner. | 1 day | No |