VERGEZ
Toulouse, 31059, France
Completed
NCT Number: NCT02397148
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.
Completed
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
computed tomography
Radiationimagery with ionizing radiation
Cone Beam Computed Tomography
Radiationimagery with ionizing radiation
Primary outcomes
-
intraclass correlation coefficient
Time frame: 1 day
Assessment of the morphological concordance between the CT and the Cone Beam in the sinus imagery with 26 validated items.
Secondary outcomes
-
morphological concordance between cone beam and CT
Time frame: 1 day
Assessment of the morphological concordance between the CT and the Cone Beam in the sinus imagery with these 26 items assessed separately
-
reproductibility INTER-OBSERVER
Time frame: 1 day
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
-
dosimetry
Time frame: 1 day
Assessment of the dosimetry CT/ Cone Beam
-
Diagnosis concordance radio-endoscopic and radio-surgical
Time frame: 1 day
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.
Sponsors and collaborators
Lead sponsor
University Hospital, Toulouse
Other
Registry information
Acronym: COSINUS
Important dates
- Study start
- 2013
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Mar 24, 2015
- Registry last updated
- Apr 9, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.