NCT02397148

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 9, 2026

Status Verified

October 1, 2016

Enrollment Period

2.5 years

First QC Date

March 4, 2015

Last Update Submit

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

EXPERIMENTAL

Computed Tomography Cone Beam Computed Tomography

Radiation: Computed TomographyRadiation: Cone Beam Computed Tomography

Interventions

imagery with ionizing radiation

patients with sinonasal pathology

imagery with ionizing radiation

patients with sinonasal pathology

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

Study Officials

  • Sebastien VERGEZ, PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

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

Locations