Sinonasal PathologiesCOSINUSNCT02397148
Assessment of the Morphological Concordance Between CT and Cone Beam in Sinus Imagery
A study testing Computed Tomography and Cone Beam Computed Tomography in people with Sinonasal Pathologies, run by University Hospital, Toulouse at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sinonasal Pathologies
- What is being tested?
- Computed Tomography and Cone Beam Computed Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2013to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Deprivation of liberty by administrative or legal decision
- patients under 18 years old
- Patients in emergency
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sinonasal Pathologies
- Being tested
- Computed Tomography, Cone Beam Computed Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyRadiation
imagery with ionizing radiation
Cone Beam Computed TomographyRadiation
imagery with ionizing radiation
| Study group | Role | What they receive |
|---|---|---|
| patients with sinonasal pathology | Experimental | Computed Tomography Cone Beam Computed Tomography Receives: Radiation: Computed Tomography; Radiation: Cone Beam Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraclass correlation coefficient
Assessment of the morphological concordance between the CT and the Cone Beam in the sinus imagery with 26 validated items.
Measured: 1 day
Secondary outcomes (4)
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
Measured: 1 day
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
Measured: 1 day
dosimetry
Assessment of the dosimetry CT/ Cone Beam
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startAug 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sinonasal PathologiesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastien VERGEZ, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397148
- Sponsor's protocol ID
- 13 147 03
- Other IDs
- 2013-A00736-39
- Acronym
- COSINUS
- Status last verified
- Oct 2016
- First submitted
- 4 Mar 2015
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Demeslay J, Vergez S, Serrano E, Chaynes P, Cantet P, Chaput B, de Bonnecaze G. Morphological concordance between CBCT and MDCT: a paranasal sinus-imaging anatomical study. Surg Radiol Anat. 2016 Jan;38(1):71-8. doi: 10.1007/s00276-015-1509-5. Epub 2015 Aug 4.
PubMed 26239897
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Morphological Concordance Between CT and Cone Beam in Sinus Imagery
- ClinicalTrials.gov ID
- NCT02397148
- Acronym / sponsor ID
- COSINUS / 13 147 03
- Conditions
- Sinonasal Pathologies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with sinonasal pathology | Experimental | Radiation: Computed Tomography, Radiation: Cone Beam Computed TomographyComputed Tomography Cone Beam Computed Tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Deprivation of liberty by administrative or legal decision
- patients under 18 years old
- Patients in emergency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed Tomographyimagery with ionizing radiation | Radiation | patients with sinonasal pathology |
| Cone Beam Computed Tomographyimagery with ionizing radiation | Radiation | patients with sinonasal pathology |
Primary outcome
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.
4 secondary outcomes
morphological concordance between cone beam and CT
Time frame: 1 day
reproductibility INTER-OBSERVER
Time frame: 1 day
dosimetry
Time frame: 1 day
Diagnosis concordance radio-endoscopic and radio-surgical
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Results publication: PubMed 26239897Demeslay J, Vergez S, Serrano E, Chaynes P, Cantet P, Chaput B, de Bonnecaze G. Morphological concordance between CBCT and MDCT: a paranasal sinus-imaging anatomical study. Surg Radiol Anat. 2016 Jan;38(1):71-8. doi: 10.1007/s00276-015-1509-5. Epub 2015 Aug 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastien VERGEZ, PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed Tomography and Cone Beam Computed Tomography in people with Sinonasal Pathologies, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraclass correlation coefficient (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02397148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.