Assessment of the Morphological Concordance Between CT and Cone Beam in Sinus Imagery
COSINUS
2 other identifiers
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 4, 2015
CompletedFirst Posted
Study publicly available on registry
March 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedApril 9, 2026
October 1, 2016
2.5 years
March 4, 2015
April 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
morphological concordance between cone beam and CT
1 day
reproductibility INTER-OBSERVER
1 day
dosimetry
1 day
Diagnosis concordance radio-endoscopic and radio-surgical
1 day
Study Arms (1)
patients with sinonasal pathology
EXPERIMENTALComputed Tomography Cone Beam Computed Tomography
Interventions
imagery with ionizing radiation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Deprivation of liberty by administrative or legal decision
- patients under 18 years old
- Patients in emergency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VERGEZ
Toulouse, 31059, France
Related Publications (1)
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.
PMID: 26239897RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastien VERGEZ, PhD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2015
First Posted
March 24, 2015
Study Start
August 1, 2013
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
April 9, 2026
Record last verified: 2016-10