Anatomic AbnormalityAMENCT04864730
Modal Anatomy of the Ethmoid Bone
An observational study of Anatomic Abnormality, run by Central Hospital, Nancy, France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Abnormality
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2021to 1 Sep 2021
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients who had a sinus CT-scan during the 2016-2019 period.
Who may be able to join
- All individuals (>18 years all) with a sinus CT scan available in the CHRU database
Who cannot join
- inflammatory sinus disease (eg. nasal polyposis, aspergilloma, ...) evolutive sinus tumor anatomical abnormality (e.g. post traumatic, prior sinus surgery, embryologic abnormality...)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Constitution d'un modèle 3D d'Anatomie Modale de L'Ethmoide Par intégration de Multiples Instances d'Acquisition
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.
Read the detailed description
Non-interventional descriptive research.
Sinus CTscans (period 2016-2019) will be reviewed from the PACS database of the CHRU of Nancy and selected in individuals without sinus pathology. All CT-scans will be fully anonymized. 26 landmarks will be pointed out to enable :
- prior images alignment (centering on the median line, realignment rotations then resizing)
- a mean and median calculation, allowing to establish a mean and median ethmoid model
- calculation of standard deviations for each voxel The structures obtained in this way (bone, tissue or aerial) will be described anatomically.
- Conditions
- Anatomic Abnormality
- Being tested
- No intervention
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| CT scans | No intervention Data of voxels will be integrated to the final model Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start15 Jul 2021 (estimated)
- Primary completion30 Aug 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic AbnormalityStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Docteur Patrice GALLET, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864730
- Sponsor's protocol ID
- 2020PI160
- Acronym
- AME
- Status last verified
- Sep 2020
- First submitted
- 10 Sep 2020
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constitution d'un modèle 3D d'Anatomie Modale de L'Ethmoide Par intégration de Multiples Instances d'Acquisition
- ClinicalTrials.gov ID
- NCT04864730
- Acronym / sponsor ID
- AME / 2020PI160
- Conditions
- Anatomic Abnormality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 Jul 2021 (estimated)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 29 Apr 2021 (actual)
- 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.
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.
Detailed description
Non-interventional descriptive research.
Sinus CTscans (period 2016-2019) will be reviewed from the PACS database of the CHRU of Nancy and selected in individuals without sinus pathology. All CT-scans will be fully anonymized. 26 landmarks will be pointed out to enable :
- prior images alignment (centering on the median line, realignment rotations then resizing)
- a mean and median calculation, allowing to establish a mean and median ethmoid model
- calculation of standard deviations for each voxel The structures obtained in this way (bone, tissue or aerial) will be described anatomically.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT scans | – | Other: No interventionNo intervention Data of voxels will be integrated to the final model |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who had a sinus CT-scan during the 2016-2019 period.
Key inclusion criteria (1 listed)
- All individuals (>18 years all) with a sinus CT scan available in the CHRU database
Key exclusion criteria (1 listed)
- inflammatory sinus disease (eg. nasal polyposis, aspergilloma, ...) evolutive sinus tumor anatomical abnormality (e.g. post traumatic, prior sinus surgery, embryologic abnormality...)
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 |
|---|---|---|
| No interventionNo intervention | Other | CT scans |
Primary outcome
Descriptive study of the anatomy of the final 3D model
Time frame: 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)
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."
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Anatomic Abnormality, run by Central Hospital, Nancy, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrice Gallet (0383155419, patrice.gallet@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive study of the anatomy of the final 3D model (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2021.