Nasal DisorderNCT03222934
A Multislice Computed Tomographic Study of the Sphenoid Sinus
An observational study of Nasal Disorder, run by Assiut University at 1 site in Egypt.
Trial summary
•Sphenoid sinus is located in the body of sphenoid bone, closed with a thin plate of bone tissue that separates it from the surrounding important structures .Detailed, meticulous preoperative radiological study of sphenoid sinus is the key to successful and safe functional endoscopic sinus surgery and transsphenoidal… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nasal Disorder
- What is being tested?
- multislice computed tomography
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Sep 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with nasal disorders with free sphenoid sinus
Who may be able to join
- patients with free sphenoid sinus
Who cannot join
- pathology in the sphenoid sinus
- refusal of patients for inclusion in the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut University
Asyut
Akram Shahat, MBBCh, 00201092626189, akramshahat91@yahoo.com
About this study
•Sphenoid sinus is located in the body of sphenoid bone, closed with a thin plate of bone tissue that separates it from the surrounding important structures .Detailed, meticulous preoperative radiological study of sphenoid sinus is the key to successful and safe functional endoscopic sinus surgery and transsphenoidal surgery. The purpose of the study is to delineate the sphenoid sinus radiologically using the multislice computed tomography and to decrease morbidity and mortality during skull base surgeries as the sphenoid sinus is one of the most variable of all sinuses and its relation to vital vascular and nervous elements make its approach a challenge for endoscopic surgeons
Read the detailed description
Sphenoid sinus is located in the body of sphenoid bone, closed with a thin plate of bone tissue that separates it from the surrounding important structures such as the optic nerve, optic chiasm, cavernous sinus, pituitary gland, and internal carotid artery. Detailed, meticulous preoperative radiological study of sphenoid sinus variations as in Onodi cells (Sphenoethmoidal air cell) is an anatomical variant of the paranasal sinuses, important due to its close proximity to the optic nerve and internal carotid artery. , Pnumatization pattern as the extent of pneumatization is highly variable and potentially jeopardizing to surrounding vital structures , Septation pattern , Intercarotid distance (in millimeters), Bony covering of carotid artery, Bony covering of optic nerve.is the key to successful and safe functional endoscopic sinus surgery and transsphenoidal surgery. The purpose of the study is to delineate the sphenoid sinus radiologically using the multislice computed tomography and to decrease morbidity and mortality during skull base surgeries as the sphenoid sinus is one of the most variable of all sinuses and its relation to vital vascular and nervous elements make its approach a challenge for endoscopic surgeons
- Conditions
- Nasal Disorder
- Being tested
- multislice computed tomography
- Medical subject headings
- Nose Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multislice computed tomographyDevice
radiological diagnosis of the status and variations in the sphenoid sinus
| Study group | Role | What they receive |
|---|---|---|
| Nasal disorders | patients with nasal disorders with free sphenoid sinus Receives: Device: multislice computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of anatomical variations of the sphenoid sinus
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Apr 2018 (estimated)
- Study completion1 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akram Shahat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222934
- Sponsor's protocol ID
- ASOM
- Status last verified
- Jul 2017
- First submitted
- 17 Jul 2017
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multislice Computed Tomographic Study of the Sphenoid Sinus
- ClinicalTrials.gov ID
- NCT03222934
- Acronym / sponsor ID
- ASOM
- Conditions
- Nasal Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Apr 2018 (estimated)
- Study completion
- 1 Sep 2018 (estimated)
- First posted
- 19 Jul 2017 (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.
•Sphenoid sinus is located in the body of sphenoid bone, closed with a thin plate of bone tissue that separates it from the surrounding important structures .Detailed, meticulous preoperative radiological study of sphenoid sinus is the key to successful and safe functional endoscopic sinus surgery and transsphenoidal surgery. The purpose of the study is to delineate the sphenoid sinus radiologically using the multislice computed tomography and to decrease morbidity and mortality during skull base surgeries as the sphenoid sinus is one of the most variable of all sinuses and its relation to vital vascular and nervous elements make its approach a challenge for endoscopic surgeons
Detailed description
Sphenoid sinus is located in the body of sphenoid bone, closed with a thin plate of bone tissue that separates it from the surrounding important structures such as the optic nerve, optic chiasm, cavernous sinus, pituitary gland, and internal carotid artery. Detailed, meticulous preoperative radiological study of sphenoid sinus variations as in Onodi cells (Sphenoethmoidal air cell) is an anatomical variant of the paranasal sinuses, important due to its close proximity to the optic nerve and internal carotid artery. , Pnumatization pattern as the extent of pneumatization is highly variable and potentially jeopardizing to surrounding vital structures , Septation pattern , Intercarotid distance (in millimeters), Bony covering of carotid artery, Bony covering of optic nerve.is the key to successful and safe functional endoscopic sinus surgery and transsphenoidal surgery. The purpose of the study is to delineate the sphenoid sinus radiologically using the multislice computed tomography and to decrease morbidity and mortality during skull base surgeries as the sphenoid sinus is one of the most variable of all sinuses and its relation to vital vascular and nervous elements make its approach a challenge for endoscopic surgeons
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal disorders | – | Device: multislice computed tomographypatients with nasal disorders with free sphenoid sinus |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with nasal disorders with free sphenoid sinus
Key inclusion criteria (1 listed)
- patients with free sphenoid sinus
Key exclusion criteria (2 listed)
- pathology in the sphenoid sinus
- refusal of patients for inclusion in the study
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 |
|---|---|---|
| multislice computed tomographyradiological diagnosis of the status and variations in the sphenoid sinus | Device | Nasal disorders |
Primary outcome
The rate of anatomical variations of the sphenoid sinus
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Disorder, run by Assiut University at 1 site in Egypt.
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 2 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 19 Jul 2017. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Akram Shahat, MBBCh (00201092626189, akramshahat91@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of anatomical variations of the sphenoid sinus (time frame: 30 minutes). 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 19 Jul 2017.