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RecruitingNCT07431125Updated Jul 24, 2026

Surgical-Clinical Correlation in Unilateral Conductive Hearing Loss With Intact Tympanic Membrane

An interventional study of Exporlation Tympanotomy in Conductive Hearing Loss, Unilateral, sponsored by Al-Azhar University. Recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Conductive Hearing Loss, Unilateral

Keywords

  • Otoscelrosis
  • Exploration Tympanotomy
  • stapedectomy
  • tympanic membrane
  • conductive hearing loss
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    Patients presented with unilatral conductive hearing loss with intact tympanic memebrane

    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

    Procedure: Exporlation Tympanotomy

Interventions

  • ProcedureExporlation Tympanotomy

    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

05

What researchers measure

Primary outcomes

  1. Improvement of the Airborne ( conductive ) gap

    Difference between preoperative and postoperative Average Airbone gap in dicebel

    Time frame: up to three months Surgery

06

Study locations

1 of 1 sites recruiting
  • Alazhar university Hopital in Assiut
    Asyut, Asyut Governorate 17511, Egypt
    Recruiting
07

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07431125
Lead sponsor
Al-Azhar University
Responsible party
Ahmed Nabil Selim (Resident doctor of otorhinolarngolgoy, Al-Azhar University) — Principal investigator
First posted
Feb 24, 2026
Start date
Jan 1, 2026
Primary completion
Aug 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Jul 24, 2026

Study contacts

tarek Mansour, head of research committe
Contact
ethicscommitt0ee@azhar.edu.eg
+0201006237731

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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