AtresiaNCT06890442
Skull Bon Variations in Patient with Congenital Unilatral Choanal Atresia
An observational study of Atresia, run by Assiut University.
Trial summary
Identify skull bone Associated Anomalies in patients with cngenital unilatral choanal atresia Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Atresia
- What is being tested?
- CT
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include patients diagnosed with congenital unilateral choanal atresia (CUCA). The inclusion and exclusion criteria will ensure a well-defined and homogenous group for analysis.
Who may be able to join
- clinical diagnosis of Congenital Unilateral Choanal Atresia
Who cannot join
- Patients with severe craniofacial syndromes
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mohamed Azam Abdelrazek, Professor contact
About this study
Official title: Associated Radiological Variations in the Skull Bones in Patients with Cong: Unilateral Choanal Atresia
Identify skull bone Associated Anomalies in patients with cngenital unilatral choanal atresia
Read the detailed description
Choanal atresia is a rare congenital disorder caused by a failure to develop the posterior nasal cavity (choana), resulting in a missing opening between the nasopharynx and the nasal cavities.It is the most common congenital anatomical abnormality of the nasal cavities with incidence ratio approximately 1/5000-7000 live births
Generally, choanal atresia may affect one or both Choanae, although most studies show that the unilateral form is more common than the bilateral one,and the incidence is higher in females than in males Children with unilateral choanal atresia are subject to unilateral breathing usually have late unilateral nasal obstruction, persistent ipsilateral rhinorrhea, and recurrent rhinosiusitis Previous studies have shown that the ratio of bone to membranous atresia is 9:1; although a detailed review of CT findings with histopathological studies showed that mixed-wall atresia is the most common and is present in 71% of cases, while in 29% of cases we found a pure bone wall Computer tomography (CT) is presently the golden standard in diagnostics of nasal cavity diseases; thus, it can be applied successfully as a tool for assessing anatomical structures
- Conditions
- Atresia
- Being tested
- CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTDevice
Thickened Medial Pterygoid Plates In bony atresia, excessive thickening of the medial pterygoid plates is common. Narrowing or Fusion of the Posterior Choanae Complete bony or membranous obstruction at the choanal opening. Abnormal Sphenoid Bone Development Hypoplasia or deformity in the sphenoid sinus, affecting adjacent structures. Vomer Deviation or Hypertrophy The vomer bone is often displaced or abnormally thickened, contributing to obstruction.
Abnormal Development of the Hard Palate
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological Variations in Skull Bones in Patients with Congenital Unilateral Choanal Atresia: A Cross-Sectional Study"
Degree and Type of Skull Bone Anomalies Presence and extent of bony abnormalities in the skull base (e.g., sphenoid bone asymmetry, pterygoid plate thickening) Degree of nasal cavity narrowing and choanal obstruction Associated maxillofacial bone abnormalities (e.g., septal deviation, maxillary sinus hypoplasia)
- Measurement of Specific Skull Bone Changes
Thickness of the atretic plate (bony vs. membranous) Asymmetry of pterygoid plates (measured in mm) Deviation angle of the nasal septum (in degrees) Orbital and maxillary asymmetry
Measured: 10_12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtresiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Sayed Mohamed Moaz, Assiut University
- Investigators
- Ahmed Ragab Sayed, Lecturer, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890442
- Sponsor's protocol ID
- Skull bon in CUCA patient
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kwong KM. Current Updates on Choanal Atresia. Front Pediatr. 2015 Jun 9;3:52. doi: 10.3389/fped.2015.00052. eCollection 2015.
PubMed 26106591
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associated Radiological Variations in the Skull Bones in Patients with Cong: Unilateral Choanal Atresia
- ClinicalTrials.gov ID
- NCT06890442
- Acronym / sponsor ID
- Skull bon in CUCA patient
- Conditions
- Atresia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 24 Mar 2025 (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.
Identify skull bone Associated Anomalies in patients with cngenital unilatral choanal atresia
Detailed description
Choanal atresia is a rare congenital disorder caused by a failure to develop the posterior nasal cavity (choana), resulting in a missing opening between the nasopharynx and the nasal cavities.It is the most common congenital anatomical abnormality of the nasal cavities with incidence ratio approximately 1/5000-7000 live births
Generally, choanal atresia may affect one or both Choanae, although most studies show that the unilateral form is more common than the bilateral one,and the incidence is higher in females than in males Children with unilateral choanal atresia are subject to unilateral breathing usually have late unilateral nasal obstruction, persistent ipsilateral rhinorrhea, and recurrent rhinosiusitis Previous studies have shown that the ratio of bone to membranous atresia is 9:1; although a detailed review of CT findings with histopathological studies showed that mixed-wall atresia is the most common and is present in 71% of cases, while in 29% of cases we found a pure bone wall Computer tomography (CT) is presently the golden standard in diagnostics of nasal cavity diseases; thus, it can be applied successfully as a tool for assessing anatomical structures
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include patients diagnosed with congenital unilateral choanal atresia (CUCA). The inclusion and exclusion criteria will ensure a well-defined and homogenous group for analysis.
Key inclusion criteria (1 listed)
- clinical diagnosis of Congenital Unilateral Choanal Atresia
Key exclusion criteria (1 listed)
- Patients with severe craniofacial syndromes
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 |
|---|---|---|
| CTThickened Medial Pterygoid Plates In bony atresia, excessive thickening of the medial pterygoid plates is common. Narrowing or Fusion of the Posterior Choanae Complete bony or membranous obstruction at the choanal opening. Abnormal Sphenoid Bone Development Hypoplasia or deformity in the sphenoid sinus, affecting adjacent structures. Vomer Deviation or Hypertrophy The vomer bone is often displaced or abnormally thickened, contributing to obstruction. Abnormal Development of the Hard Palate | Device | – |
Primary outcome
Radiological Variations in Skull Bones in Patients with Congenital Unilateral Choanal Atresia: A Cross-Sectional Study"
Time frame: 10_12 month
Degree and Type of Skull Bone Anomalies Presence and extent of bony abnormalities in the skull base (e.g., sphenoid bone asymmetry, pterygoid plate thickening) Degree of nasal cavity narrowing and choanal obstruction Associated maxillofacial bone abnormalities (e.g., septal deviation, maxillary sinus hypoplasia) 2. Measurement of Specific Skull Bone Changes Thickness of the atretic plate (bony vs. membranous) Asymmetry of pterygoid plates (measured in mm) Deviation angle of the nasal septum (in degrees) Orbital and maxillary asymmetry
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Background: PubMed 26106591Kwong KM. Current Updates on Choanal Atresia. Front Pediatr. 2015 Jun 9;3:52. doi: 10.3389/fped.2015.00052. eCollection 2015.
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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.
Mohamed Azam Abdelrazek, Professor contact
Ahmed Ragab Sayed, Lecturer principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Atresia, run by Assiut University.
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: opening soon, as of the sponsor's last update on 24 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Sayed Moaz, Master (0201063390574, ahmoooodz857@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological Variations in Skull Bones in Patients with Congenital Unilateral Choanal Atresia: A Cross-Sectional Study" (time frame: 10_12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06890442, which also lists 1 linked publication.
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 24 Mar 2025.