NCT04864730

Brief Summary

The creation of a 3D model of modal anatomy of the ethmoid could, like other parts of the body, improve anatomical, radiological and perhaps even surgical learning. Anatomical variations might constitute a "background noise" of the modal anatomy, which can be attenuated by multiplying the instances of acquisitions. The objective of this work is to establish modal anatomy of the ethmoid by the analysis of a large number of CT-scan acquisitions carried out in individuals with no acquired sinus pathology.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

September 10, 2020

Completed
8 months until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

June 22, 2021

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

September 10, 2020

Last Update Submit

June 19, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Descriptive study of the anatomy of the final 3D model

    Descriptive study The study aims to produce the "modal" (generic) model from all the individual sub-models. The structures obtained will be described anatomically by ENT experts: the created model will be described in comparison with anatomical data from literature: constant structures (e.g. middle turbinate, inferior turbinate, or orbital wall) will be listed and described (sites of insertion, direction, form), while variations in anatomical structures will be described through the variance (variances of voxels, pooled for each anatomical sub-site) (e.g. anterior ethmoid, sphenoid...). The heat map of voxels' variances will be superposed on the final model. No scale/physiological parameter/questionnaire can be used for anatomical description of a single model. Therefore we don't really understand your remark "Please further specify the measurement that will be used (e.g., descriptive name of scale, physiological parameter, questionnaire) to assess this outcome measure."

    Through completion of the study: 1 month (The model will be available only at the end of the study, after implementation of all CT-scans)

Study Arms (1)

CT scans

No intervention Data of voxels will be integrated to the final model

Other: No intervention

Interventions

No intervention

CT scans

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who had a sinus CT-scan during the 2016-2019 period.

You may qualify if:

  • All individuals (\>18 years all) with a sinus CT scan available in the CHRU database

You may not qualify if:

  • inflammatory sinus disease (eg. nasal polyposis, aspergilloma, ...) evolutive sinus tumor anatomical abnormality (e.g. post traumatic, prior sinus surgery, embryologic abnormality...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 10, 2020

First Posted

April 29, 2021

Study Start

July 15, 2021

Primary Completion

August 30, 2021

Study Completion

September 1, 2021

Last Updated

June 22, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share