Conductive Hearing Loss, UnilateralNCT07431125
Surgical-Clinical Correlation in Unilateral Conductive Hearing Loss With Intact Tympanic Membrane
A study testing Exporlation Tympanotomy in people with Conductive Hearing Loss, Unilateral, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Unilateral conductive hearing loss (UCHL) in the presence of an intact tympanic membrane represents a diagnostic challenge in otologic practice. In the absence of middle ear effusion or tympanic membrane pathology, stapes fixation secondary to otosclerosis is often considered the most probable diagnosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Conductive Hearing Loss, Unilateral
- What is being tested?
- Exporlation Tympanotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to Aug 2026
- 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
- unilateral conductive hearing loss or mixed HL with intact Tympanic Membrane
- Average Airborne Gap Above 20 decibels Exclusion Criteria
- Sensorineural hearing loss
- Chronic otitis media
- TM perforation
- Previous ear surgery
Who cannot join
None listed.
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, 1 recruiting
- Recruiting
Alazhar university Hopital in Assiut
Asyut, Asyut Governorate, 17511
tarek mansour, head of research committe, 0201006237731, ethicscommitt0ee@azhar.edu.eg
About this study
Unilateral conductive hearing loss (UCHL) in the presence of an intact tympanic membrane represents a diagnostic challenge in otologic practice. In the absence of middle ear effusion or tympanic membrane pathology, stapes fixation secondary to otosclerosis is often considered the most probable diagnosis. However, although otosclerosis is traditionally regarded as a bilateral disease, clinical presentation may be unilateral due to asymmetric disease progression or subclinical contralateral involvement. Other etiologies, including congenital ossicular anomalies, ossicular discontinuity, tympanosclerosis without tympanic membrane involvement, or oval window abnormalities, may mimic otosclerosis both clinically and audiologically. Consequently, exploratory tympanotomy remains the gold standard for definitive diagnosis, allowing direct assessment of ossicular chain mobility and confirmation of stapes fixation. Correlating preoperative clinical suspicion with intraoperative findings is therefore essential to better define the true causes of unilateral conductive hearing loss with an intact tympanic membrane.
- Conditions
- Conductive Hearing Loss, Unilateral
- Being tested
- Exporlation Tympanotomy
- Keywords
- Otoscelrosis, Exploration Tympanotomy, stapedectomy, tympanic membrane, conductive hearing loss
- Medical subject headings
- Hearing Loss, Conductive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exporlation TympanotomyProcedure or surgery
exploration tympanotomy of the middle ear and ossicles to diagnose or detect actual causes of conductive hearing loss and correct it according to the cause
| Study group | Role | What they receive |
|---|---|---|
| Patients presented with unilatral conductive hearing loss with intact tympanic memebrane | Other | Patients who presented with unilateral conductive hearing loss with intact tympanic membrane will undergo exploration tympanoplasty to diagnose underlying causes and correct them surgically if possible Receives: Procedure: Exporlation Tympanotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of the Airborne ( conductive ) gap
Difference between preoperative and postoperative Average Airbone gap in dicebel
Measured: up to three months Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Jan 2026
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conductive Hearing Loss, UnilateralStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Nabil Selim, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431125
- Sponsor's protocol ID
- MSCAZASTENT020752792026
- Status last verified
- Jan 2026
- First submitted
- 19 Feb 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional ethical restrictions and the retrospective nature of the study. The dataset contains potentially identifiable clinical and surgical information. De-identified aggregated data may be made available upon reasonable request to the corresponding author, subject to institutional review and approval.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical-Clinical Correlation in Unilateral Conductive Hearing Loss With Intact Tympanic Membrane
- ClinicalTrials.gov ID
- NCT07431125
- Acronym / sponsor ID
- MSCAZASTENT020752792026
- Conditions
- Conductive Hearing Loss, Unilateral
- Keywords
- Otoscelrosis, Exploration Tympanotomy, stapedectomy, tympanic membrane, conductive hearing loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 24 Feb 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.
Unilateral conductive hearing loss (UCHL) in the presence of an intact tympanic membrane represents a diagnostic challenge in otologic practice. In the absence of middle ear effusion or tympanic membrane pathology, stapes fixation secondary to otosclerosis is often considered the most probable diagnosis. However, although otosclerosis is traditionally regarded as a bilateral disease, clinical presentation may be unilateral due to asymmetric disease progression or subclinical contralateral involvement. Other etiologies, including congenital ossicular anomalies, ossicular discontinuity, tympanosclerosis without tympanic membrane involvement, or oval window abnormalities, may mimic otosclerosis both clinically and audiologically. Consequently, exploratory tympanotomy remains the gold standard for definitive diagnosis, allowing direct assessment of ossicular chain mobility and confirmation of stapes fixation. Correlating preoperative clinical suspicion with intraoperative findings is therefore essential to better define the true causes of unilateral conductive hearing loss with an intact tympanic membrane.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients presented with unilatral conductive hearing loss with intact tympanic memebrane | Other | Procedure: Exporlation TympanotomyPatients who presented with unilateral conductive hearing loss with intact tympanic membrane will undergo exploration tympanoplasty to diagnose underlying causes and correct them surgically if possible |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- unilateral conductive hearing loss or mixed HL with intact Tympanic Membrane
- Average Airborne Gap Above 20 decibels Exclusion Criteria
- Sensorineural hearing loss
- Chronic otitis media
- TM perforation
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Exporlation Tympanotomyexploration tympanotomy of the middle ear and ossicles to diagnose or detect actual causes of conductive hearing loss and correct it according to the cause | Procedure or surgery | Patients presented with unilatral conductive hearing loss with intact tympanic memebrane |
Primary outcome
Improvement of the Airborne ( conductive ) gap
Time frame: up to three months Surgery
Difference between preoperative and postoperative Average Airbone gap in dicebel
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 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional ethical restrictions and the retrospective nature of the study. The dataset contains potentially identifiable clinical and surgical information. De-identified aggregated data may be made available upon reasonable request to the corresponding author, subject to institutional review and approval.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exporlation Tympanotomy in people with Conductive Hearing Loss, Unilateral, 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 6 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 24 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 tarek Mansour, head of research committe (+0201006237731, ethicscommitt0ee@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of the Airborne ( conductive ) gap (time frame: up to three months Surgery). 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 24 Jul 2026.