Computer AssistedNCT07575022
Computer Assisted Navigation on Endoscopic Sinus Surgery for Treatment of Sinonasal Polyposis
An observational study of Computer Assisted and Navigation, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study aimed to compare Endoscopic Sinus Surgery with and without image guidance, analyzing a number of parameters that can impact efficacy in cases of nasal polyposis. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Computer Assisted, Navigation, Endoscopic Sinus Surgery
- What is being tested?
- Endoscopic sinus surgery with Computer Assisted Navigation and Endoscopic sinus surgery
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Jun 2024
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This Prospective comparative study was carried out on 40 patients aged from above 15 and below 70 years old, both sexes, with nasal polyposis undergoing ESS whether primary or revision cases. The study was done after approval from the Ethical Committee Al Azhar University, Cairo, Egypt.
Who may be able to join
- Age from 15 to 70 years.
- Both sex.
- Patients with nasal polyposis undergoing endoscopic sinus surgery (ESS) whether primary or revision cases.
Who cannot join
- Patients with nasal polyposis not undergoing ESS.
- Patients with any severe cardiac diseases, pregnant females, transplant patients and patients with psychiatric illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Computer Assisted Navigation on Endoscopic Sinus Surgery for Treatment of Sinonasal Polyposis
This study aimed to compare Endoscopic Sinus Surgery with and without image guidance, analyzing a number of parameters that can impact efficacy in cases of nasal polyposis.
Read the detailed description
Endoscopic sinus surgery (ESS) is a treatment of choice for rhinosinusitis (CRS), sinonasal polyposis and in cases of skull base diseases. Despite the availability of excellent nasal telescopes and high-resolution preoperative computed tomography (CT), incidence of complications in endoscopic sinus surgery is of 0-1.5% for the major and 1.1-20.8% for the minor.
Electromagnetic and optical localization systems both enable real-time detection of instrument position in a 3D imaging repository. At present, such repositories are exclusively based on CT acquisitions reformatted to obtain a series of slices in three dimensions. A software interface matches the imaging repository to a peroperative spatial repository in which the instrument can be located.
- Being tested
- Endoscopic sinus surgery with Computer Assisted Navigation, Endoscopic sinus surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic sinus surgery with Computer Assisted NavigationProcedure or surgery
Patients with nasal polyposis undergoing endoscopic sinus surgery with Computer Assisted Navigation.
Endoscopic sinus surgeryProcedure or surgery
Patients with nasal polyposis undergoing endoscopic sinus surgery only.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Patients with nasal polyposis undergoing endoscopic sinus surgery with Computer Assisted Navigation. Receives: Procedure: Endoscopic sinus surgery with Computer Assisted Navigation | |
| Group II | Patients with nasal polyposis undergoing endoscopic sinus surgery only. Receives: Procedure: Endoscopic sinus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Recurrence rate was recorded.
Measured: 3 months after the procedure
Secondary outcomes (2)
Incidence of major complications
Incidence of major complications like cerebrospinal fluid (CSF) leakage, Carotid artery injury, Brain injury, Blindness, Orbital hematoma and persistent diplopia were recorded.
Measured: 3 months after the procedure
Incidence of minor complications
Incidence of minor complications like Orbital fat extrusion, Bleeding, Dural exposure, Nasolacrimal duct injury, Synechiae and edema were recorded
Measured: 3 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Jun 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Computer AssistedStudies of the same condition, open and under way.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelhameed Hassan Abdelhameed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575022
- Sponsor's protocol ID
- 1690
- Status last verified
- May 2026
- First submitted
- 3 May 2026
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Computer Assisted Navigation on Endoscopic Sinus Surgery for Treatment of Sinonasal Polyposis
- ClinicalTrials.gov ID
- NCT07575022
- Acronym / sponsor ID
- 1690
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 8 May 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.
This study aimed to compare Endoscopic Sinus Surgery with and without image guidance, analyzing a number of parameters that can impact efficacy in cases of nasal polyposis.
Detailed description
Endoscopic sinus surgery (ESS) is a treatment of choice for rhinosinusitis (CRS), sinonasal polyposis and in cases of skull base diseases. Despite the availability of excellent nasal telescopes and high-resolution preoperative computed tomography (CT), incidence of complications in endoscopic sinus surgery is of 0-1.5% for the major and 1.1-20.8% for the minor.
Electromagnetic and optical localization systems both enable real-time detection of instrument position in a 3D imaging repository. At present, such repositories are exclusively based on CT acquisitions reformatted to obtain a series of slices in three dimensions. A software interface matches the imaging repository to a peroperative spatial repository in which the instrument can be located.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Procedure: Endoscopic sinus surgery with Computer Assisted NavigationPatients with nasal polyposis undergoing endoscopic sinus surgery with Computer Assisted Navigation. |
| Group II | – | Procedure: Endoscopic sinus surgeryPatients with nasal polyposis undergoing endoscopic sinus surgery only. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This Prospective comparative study was carried out on 40 patients aged from above 15 and below 70 years old, both sexes, with nasal polyposis undergoing ESS whether primary or revision cases. The study was done after approval from the Ethical Committee Al Azhar University, Cairo, Egypt.
Key inclusion criteria (3 listed)
- Age from 15 to 70 years.
- Both sex.
- Patients with nasal polyposis undergoing endoscopic sinus surgery (ESS) whether primary or revision cases.
Key exclusion criteria (2 listed)
- Patients with nasal polyposis not undergoing ESS.
- Patients with any severe cardiac diseases, pregnant females, transplant patients and patients with psychiatric illness.
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 surgery with Computer Assisted NavigationPatients with nasal polyposis undergoing endoscopic sinus surgery with Computer Assisted Navigation. | Procedure or surgery | Group I |
| Endoscopic sinus surgeryPatients with nasal polyposis undergoing endoscopic sinus surgery only. | Procedure or surgery | Group II |
Primary outcome
Recurrence rate
Time frame: 3 months after the procedure
Recurrence rate was recorded.
2 secondary outcomes
Incidence of major complications
Time frame: 3 months after the procedure
Incidence of minor complications
Time frame: 3 months after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Computer Assisted and Navigation, run by Al-Azhar 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 3 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: finished, as of the sponsor's last update on 8 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: 3 months after the procedure). 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 8 May 2026.