Sphenoid SinusNCT07702188
Different Endoscopic Approaches for Sphenoid Sinus
A study testing endoscopic sinus surgery in people with Sphenoid Sinus and Endoscopic Sinus Surgery, run by Assiut University at 1 site in Egypt.
Trial summary
Identification of the most effective approach for different lesion types Correlation between approach and complication rates Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sphenoid Sinus, Endoscopic Sinus Surgery
- What is being tested?
- endoscopic sinus surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to 1 Sep 2028
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with sinonasal lesions involving sphenid sinus with or without skull base extension.
Who cannot join
- Severe comorbidities contraindicating surgery
- malignant tumer extend beyond sphenoid sinus requiring open management
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University Hospital
Asyut
Doaa Mohamed, 01119015094, DoaaAraby9@aun.edu.eg
About this study
Official title: Different Approaches for Sphenoid Sinus
- Identification of the most effective approach for different lesion types
- Correlation between approach and complication rates
Read the detailed description
The sphenoid sinus is one of the most anatomically complex and surgically challenging paranasal sinuses due to its deep location ,wide anatomical variation and proximity to critical neurovascular structures.
Important structures are adjacent to the sphenoid sinus include the dura, pituitary, optic nerve, cavernous sinus, pterygoid canal and nerve, internal carotid artery, and cranial nerves III, IV, VI, V1, V2, which are vulnerable to injury with sphenoid disease.
Wide anatomical variation such as Degree of Pneumatization , Septation Patterns , Sinus Size and Shape, Ostium Location ,Onodi Cells, Prominence or dehiscence of nearby structures.
Therefore, surgeons must carefully select the extent of dissection to create a sphenoid opening that matches the patient's pathology while avoiding the risks associated with overly extensive openings and drilling, which may prolong healing and increase the likelihood of scarring and stenosis.
Diagnostic nasal endoscopy procedures and imaging techniques are of great value for an early and precise diagnosis.
Moreover, endoscopic sinus surgery is a safe and effective technique that allows a direct route to the sphenoid sinus.
Because of its close vicinity to important and vulnerable structures of the skull base, delay in diagnosis and treatment can be potentially lethal.
Sphenoid sinus lesions may range from mild, isolated inflammation to erosive tumors with cranial nerve deficits or cases requiring access to a pneumatized lateral recess .
Additionally, conditions such as tumors, encephaloceles, mucoceles, and skull base lesions demand extra preoperative planning and careful technique selection.
- Conditions
- Sphenoid Sinus, Endoscopic Sinus Surgery
- Being tested
- endoscopic sinus surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic sinus surgeryProcedure or surgery
Different approaches include:
type I, sphenoid ostial dilation. type IIa, transnasal sphenoidotomy (sphenoidotomy without ethmoidectomy). type IIb, transethmoidal sphenoidotomy (sphenoidotomy with ethmoidectomy). type III, bilateral, common cavity sphenoidotomy, or "sphenoid drill-out;" type IV, transpterygoid approach, to expose the lateral sphenoid sinus recess. type V, sphenoid nasalization, completely removing the sphenoid sinus floor.
| Study group | Role | What they receive |
|---|---|---|
| endoscopic approaches for sphenoid sinus | Experimental | type I, sphenoid ostial dilation. type IIa, transnasal sphenoidotomy (sphenoidotomy without ethmoidectomy). type IIb, transethmoidal sphenoidotomy (sphenoidotomy with ethmoidectomy). type III, bilateral, common cavity sphenoidotomy, or "sphenoid drill-out;" type IV, transpterygoid approach, to expose the lateral sphenoid sinus recess. type V, sphenoid nasalization, completely removing the sphenoid sinus floor. Receives: Procedure: endoscopic sinus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate different endoscopic surgical approaches to the sphenoid sinus
- Complete lesion removal measured by post operative imaging ct
- Complications examples Csf leakage Optic nerve injury (measured by visual acuity)
- Carotid artery injury(bleeding)
- Infection(meningitis csf examination if suspected)
Measured: 6 months
To evaluate different endoscopic surgical approaches to the sphenoid sinus regarding: * Completence of lesion removal. * Complications. - Csf leakage - Optic nerve injury
complications rate (csf leakage , optic nerve injury, carotid artery injury)
- Recurrence
- Endoscopic patency of sphenoid osteum and synechia formation
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Sep 2028 (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 Sphenoid SinusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Araby Mohamed, Assiut University
- Investigators
- mohamed modather, assistant professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702188
- Sponsor's protocol ID
- sphenoid sinus approaches
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
https://scholar.google.com/?hl=ar
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Approaches for Sphenoid Sinus
- ClinicalTrials.gov ID
- NCT07702188
- Acronym / sponsor ID
- sphenoid sinus approaches
- Conditions
- Sphenoid Sinus, Endoscopic Sinus Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 14 Jul 2026 (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.
- Identification of the most effective approach for different lesion types
- Correlation between approach and complication rates
Detailed description
The sphenoid sinus is one of the most anatomically complex and surgically challenging paranasal sinuses due to its deep location ,wide anatomical variation and proximity to critical neurovascular structures.
Important structures are adjacent to the sphenoid sinus include the dura, pituitary, optic nerve, cavernous sinus, pterygoid canal and nerve, internal carotid artery, and cranial nerves III, IV, VI, V1, V2, which are vulnerable to injury with sphenoid disease.
Wide anatomical variation such as Degree of Pneumatization , Septation Patterns , Sinus Size and Shape, Ostium Location ,Onodi Cells, Prominence or dehiscence of nearby structures.
Therefore, surgeons must carefully select the extent of dissection to create a sphenoid opening that matches the patient's pathology while avoiding the risks associated with overly extensive openings and drilling, which may prolong healing and increase the likelihood of scarring and stenosis.
Diagnostic nasal endoscopy procedures and imaging techniques are of great value for an early and precise diagnosis.
Moreover, endoscopic sinus surgery is a safe and effective technique that allows a direct route to the sphenoid sinus.
Because of its close vicinity to important and vulnerable structures of the skull base, delay in diagnosis and treatment can be potentially lethal.
Sphenoid sinus lesions may range from mild, isolated inflammation to erosive tumors with cranial nerve deficits or cases requiring access to a pneumatized lateral recess .
Additionally, conditions such as tumors, encephaloceles, mucoceles, and skull base lesions demand extra preoperative planning and careful technique selection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endoscopic approaches for sphenoid sinus | Experimental | Procedure: endoscopic sinus surgerytype I, sphenoid ostial dilation. type IIa, transnasal sphenoidotomy (sphenoidotomy without ethmoidectomy). type IIb, transethmoidal sphenoidotomy (sphenoidotomy with ethmoidectomy). type III, bilateral, common cavity sphenoidotomy, or "sphenoid drill-out;" type IV, transpterygoid approach, to expose the lateral sphenoid sinus recess. type V, sphenoid nasalization, completely removing the sphenoid sinus floor. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with sinonasal lesions involving sphenid sinus with or without skull base extension.
Key exclusion criteria (2 listed)
- Severe comorbidities contraindicating surgery
- malignant tumer extend beyond sphenoid sinus requiring open management
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 |
|---|---|---|
| endoscopic sinus surgeryDifferent approaches include: type I, sphenoid ostial dilation. type IIa, transnasal sphenoidotomy (sphenoidotomy without ethmoidectomy). type IIb, transethmoidal sphenoidotomy (sphenoidotomy with ethmoidectomy). type III, bilateral, common cavity sphenoidotomy, or "sphenoid drill-out;" type IV, transpterygoid approach, to expose the lateral sphenoid sinus recess. type V, sphenoid nasalization, completely removing the sphenoid sinus floor. | Procedure or surgery | endoscopic approaches for sphenoid sinus |
Primary outcome
To evaluate different endoscopic surgical approaches to the sphenoid sinus
Time frame: 6 months
* Complete lesion removal measured by post operative imaging ct * Complications examples Csf leakage Optic nerve injury (measured by visual acuity) * Carotid artery injury(bleeding) * Infection(meningitis csf examination if suspected)
To evaluate different endoscopic surgical approaches to the sphenoid sinus regarding: * Completence of lesion removal. * Complications. - Csf leakage - Optic nerve injury
Time frame: 6 month
complications rate (csf leakage , optic nerve injury, carotid artery injury) * Recurrence * Endoscopic patency of sphenoid osteum and synechia formation
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 14 Jul 2026.
- Backgroundhttps://scholar.google.com/?hl=ar
- Castelnuovo, P., Pagella, F., Semino, L., De Bernardi, F., \& Delù, G. (2005). Endoscopic treatment of the isolated sphenoid sinus lesions. European Archives of Oto-Rhino-Laryngology and Head \& Neck, 262(2), 142-147.Link provided by the sponsor.
- 3-Jang, J. Y., Kim, G. J., Kim, S. Y., Kim, M. S., Lee, D. K., Kwon, M., ... \& Cho, K. J. (2025). Guidelines for the treatment of laryngeal cancer from the Korean society of head and neck surgery. Clinical and experimental otorhinolaryngology, 18(2), 89-Link provided by the sponsor.
- -Lawson, W., \& Reino, A. J. (1997). Isolated sphenoid sinus disease: an analysis of 132 cases. The Laryngoscope, 107(12), 1590-1595..Link provided by the sponsor.
- Individual participant dataSharing planned: No
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 modather, assistant professor study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic sinus surgery in people with Sphenoid Sinus and Endoscopic Sinus Surgery, 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: opening soon, as of the sponsor's last update on 14 Jul 2026. 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?
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 Doaa Araby Mohamed, assistant lecturer (+201119015094, DoaaAraby9@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate different endoscopic surgical approaches to the sphenoid sinus (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT07702188, 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 14 Jul 2026.