OtosclerosisNCT07304999
Surgical and Audiological Outcomes of Endoscopic Stapes Surgery
A study testing endsocopic stapedotomy in people with Otosclerosis, run by Sohag University at 1 site in Egypt.
Trial summary
Otosclerosis is a pathological bone remodeling process that affects the middle and inner ears. It was first reported by Antonio Maria Valsalva in 1735 and subsequently described pathologically by Adam Politzer in 1839 . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Otosclerosis
- What is being tested?
- endsocopic stapedotomy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2025to Jun 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
- Patients with otosclerosis who will undergo endoscopic stapedotomy whose diagnoses are mainly based on progressive conductive deafness over 25 dB in the range of 0.25-4 kHz.
Who cannot join
- Otosclerotic patients with either isolated sensorineural or mixed deafness (bone conduction more than 30 dB), or those with small air-bone gap less than 25 dB and those complaining from vestibular symptoms in the last year prior to surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Waleed Abdelhafeez, Professor contact
About this study
Otosclerosis is a pathological bone remodeling process that affects the middle and inner ears. It was first reported by Antonio Maria Valsalva in 1735 and subsequently described pathologically by Adam Politzer in 1839 .
In otosclerosis, the normal, dense endochondral bone of the otic capsule around the inner ear labyrinth is replaced by irregularly laid spongy bone, which subsequently hardens and leads to fixation of the stapes footplate . Otosclerosis causes progressive conductive hearing loss that typically presents with a normal tympanic membrane. However, a reddish shadow on the promontory of the cochlea may be seen in some cases (Schwartze sign) if the tympanic membrane is clear enough.
Read more
Initial symptoms of otosclerosis include decreased sensitivity to low-frequency sounds, such as whispers. Patients may also paradoxically deny difficulty hearing conversation in loud background noise, which is termed "paracusis Willisii" or "paracusis of Willis,. Tinnitus may worsen as the disease progresses. Vertigo is usually mild, but as the disease progresses, balance may deteriorate, mimicking Ménière disease. .
On physical examination, patients with otosclerosis may speak in low volume and monotonous voices. Otoscopy may reveal no abnormalities at all. With active otosclerosis, however, increased vascularity of the cochlear promontory may be visible through the tympanic membrane A Weber test performed with a 512 Hz (Hertz) fork will generally lateralize toward the ear with the conductive loss or toward the ear with the greater conductive loss in cases of bilateral otosclerosis . In most cases of otosclerosis, pure tone audiometry shows low frequency decreases in air conduction thresholds. Bone conduction, however, typically remains normal. A "Carhart notch" is often seen, which is an artifactual dip in the bone conduction line by 20-30 dB(disciple) at 2,000 Hz due to the resonance frequency of the ossicular chain .
There is no medical therapy that is curative for otosclerosis. Though sodium fluoride is prescribed to slow the progression of otosclerosis, its efficacy is still controversial and In stapes surgery different surgical techniques, approaches and prostheses in order to restore sound transmission have been described. Stapedectomy was first described by Shea.Jr in 1956.
Surgical techniques for treatment of otosclerosis have been improved, updated, or adjusted over time to lower intraoperative and post-operative problems and boost overall effectiveness .
The treatment of choice is stapedotomy or stapedectomy, along with the placement of a prosthesis. In these procedures, either a hole is drilled in the center of the stapes footplate with a high-speed microdrill or a laser (stapedotomy), and a prosthesis is placed between the long process of the incus and the oval window membrane via the hole in the stapes footplate, or the stapes footplate is removed partially or in its entirety and a prosthesis placed between the incus and the oval window, typically with a vein or fascia graft used to protect the oval window membrane (stapedectomy). In both procedures, the crura of the stapes are fractured, and the incudo stapedial joint is divided in order to permit the removal of the stapes superstructure.
Surgical treatment for otosclerosis generally produces good outcomes, irrespective of the approach employed, provided appropriate patient selection. For patients with bilateral otosclerosis, the ear with greater hearing loss is typically addressed first; both ears are not operated under the same anesthetic in order to avoid the very unlikely scenario in which total sensorineural hearing loss occurs bilaterally as a result of surgery. A 2018 review published by Cheng et al indicated comparable results between stapedotomy and stapedectomy, with a slight advantage in terms of high- frequency hearing and complication rate for stapedotomy .
Microscopic trans canal or end aural approach is the most preferred technique in stapes surgery . Although microscopes provide good magnification and let both hands use, sufficient exposure of stapedial structures might not be possible under microscopic approach without bone curettage .
In microscopic approaches, extensive curettage of scutum may result in complications such as chorda tympani nerve injury, impaired taste sensation, subluxation of ossicles, retraction pockets and postoperative higher pain levels .
- Conditions
- Otosclerosis
- Being tested
- endsocopic stapedotomy
- Medical subject headings
- Otosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endsocopic stapedotomyProcedure or surgery
Patients will undergo stapedotomy by endoscopic approach and the same type of artificial loop prosthesis will be used .
Intraoperative details are recorded including invasiveness of the surgery, clarity of the exposure of the middle ear and stapedial structures , the ease of placement of the artificial loop prosthesis and also intraoperative complications.
Postoperative follow up and complications will be recorded and evaluated. Postoperative audiological evaluation, including air-conduction (AC), bone-conduction (BC) and air-bone gap (ABG), will be carried out using pure-tone audiometry and performed within 4 to 6 months after surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
hearing level
changes in air-bone gap(by decibles) by using pure tone audiometry
Measured: 6 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OtosclerosisStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Sayed Abdelrahman, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304999
- Sponsor's protocol ID
- Soh-Med-25-11-2MD
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Quinn KJ, Coelho DH. The Curious Rise and Incomplete Fall of "Paracusis Willisii". Otol Neurotol. 2022 Jan 1;43(1):137-143. doi: 10.1097/MAO.0000000000003368.
PubMed 34619730Kelly EA, Li B, Adams ME. Diagnostic Accuracy of Tuning Fork Tests for Hearing Loss: A Systematic Review. Otolaryngol Head Neck Surg. 2018 Aug;159(2):220-230. doi: 10.1177/0194599818770405. Epub 2018 Apr 17.
PubMed 29661046Cheng HCS, Agrawal SK, Parnes LS. Stapedectomy Versus Stapedotomy. Otolaryngol Clin North Am. 2018 Apr;51(2):375-392. doi: 10.1016/j.otc.2017.11.008. Epub 2018 Feb 3.
PubMed 29397948Hoskison EE, Harrop E, Jufas N, Kong JHK, Patel NP, Saxby AJ. Endoscopic Stapedotomy: A Systematic Review. Otol Neurotol. 2021 Dec 1;42(10):e1638-e1643. doi: 10.1097/MAO.0000000000003242.
PubMed 34267093
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical and Audiological Outcomes of Endoscopic Stapes Surgery
- ClinicalTrials.gov ID
- NCT07304999
- Acronym / sponsor ID
- Soh-Med-25-11-2MD
- Conditions
- Otosclerosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 26 Dec 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.
Otosclerosis is a pathological bone remodeling process that affects the middle and inner ears. It was first reported by Antonio Maria Valsalva in 1735 and subsequently described pathologically by Adam Politzer in 1839 .
In otosclerosis, the normal, dense endochondral bone of the otic capsule around the inner ear labyrinth is replaced by irregularly laid spongy bone, which subsequently hardens and leads to fixation of the stapes footplate . Otosclerosis causes progressive conductive hearing loss that typically presents with a normal tympanic membrane. However, a reddish shadow on the promontory of the cochlea may be seen in some cases (Schwartze sign) if the tympanic membrane is clear enough.
Initial symptoms of otosclerosis include decreased sensitivity to low-frequency sounds, such as whispers. Patients may also paradoxically deny difficulty hearing conversation in loud background noise, which is termed "paracusis Willisii" or "paracusis of Willis,. Tinnitus may worsen as the disease progresses. Vertigo is usually mild, but as the disease progresses, balance may deteriorate, mimicking Ménière disease. .
On physical examination, patients with otosclerosis may speak in low volume and monotonous voices. Otoscopy may reveal no abnormalities at all. With active otosclerosis, however, increased vascularity of the cochlear promontory may be visible through the tympanic membrane A Weber test performed with a 512 Hz (Hertz) fork will generally lateralize toward the ear with the conductive loss or toward the ear with the greater conductive loss in cases of bilateral otosclerosis . In most cases of otosclerosis, pure tone audiometry shows low frequency decreases in air conduction thresholds. Bone conduction, however, typically remains normal. A "Carhart notch" is often seen, which is an artifactual dip in the bone conduction line by 20-30 dB(disciple) at 2,000 Hz due to the resonance frequency of the ossicular chain .
There is no medical therapy that is curative for otosclerosis. Though sodium fluoride is prescribed to slow the progression of otosclerosis, its efficacy is still controversial and In stapes surgery different surgical techniques, approaches and prostheses in order to restore sound transmission have been described. Stapedectomy was first described by Shea.Jr in 1956.
Surgical techniques for treatment of otosclerosis have been improved, updated, or adjusted over time to lower intraoperative and post-operative problems and boost overall effectiveness .
The treatment of choice is stapedotomy or stapedectomy, along with the placement of a prosthesis. In these procedures, either a hole is drilled in the center of the stapes footplate with a high-speed microdrill or a laser (stapedotomy), and a prosthesis is placed between the long process of the incus and the oval window membrane via the hole in the stapes footplate, or the stapes footplate is removed partially or in its entirety and a prosthesis placed between the incus and the oval window, typically with a vein or fascia graft used to protect the oval window membrane (stapedectomy). In both procedures, the crura of the stapes are fractured, and the incudo stapedial joint is divided in order to permit the removal of the stapes superstructure.
Surgical treatment for otosclerosis generally produces good outcomes, irrespective of the approach employed, provided appropriate patient selection. For patients with bilateral otosclerosis, the ear with greater hearing loss is typically addressed first; both ears are not operated under the same anesthetic in order to avoid the very unlikely scenario in which total sensorineural hearing loss occurs bilaterally as a result of surgery. A 2018 review published by Cheng et al indicated comparable results between stapedotomy and stapedectomy, with a slight advantage in terms of high- frequency hearing and complication rate for stapedotomy .
Microscopic trans canal or end aural approach is the most preferred technique in stapes surgery . Although microscopes provide good magnification and let both hands use, sufficient exposure of stapedial structures might not be possible under microscopic approach without bone curettage .
In microscopic approaches, extensive curettage of scutum may result in complications such as chorda tympani nerve injury, impaired taste sensation, subluxation of ossicles, retraction pockets and postoperative higher pain levels .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with otosclerosis who will undergo endoscopic stapedotomy whose diagnoses are mainly based on progressive conductive deafness over 25 dB in the range of 0.25-4 kHz.
Key exclusion criteria (1 listed)
- Otosclerotic patients with either isolated sensorineural or mixed deafness (bone conduction more than 30 dB), or those with small air-bone gap less than 25 dB and those complaining from vestibular symptoms in the last year prior to surgery
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 |
|---|---|---|
| endsocopic stapedotomyPatients will undergo stapedotomy by endoscopic approach and the same type of artificial loop prosthesis will be used . Intraoperative details are recorded including invasiveness of the surgery, clarity of the exposure of the middle ear and stapedial structures , the ease of placement of the artificial loop prosthesis and also intraoperative complications. Postoperative follow up and complications will be recorded and evaluated. Postoperative audiological evaluation, including air-conduction (AC), bone-conduction (BC) and air-bone gap (ABG), will be carried out using pure-tone audiometry and performed within 4 to 6 months after surgery. | Procedure or surgery | – |
Primary outcome
hearing level
Time frame: 6 monthes
changes in air-bone gap(by decibles) by using pure tone audiometry
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 26 Dec 2025.
- Background: PubMed 34619730Quinn KJ, Coelho DH. The Curious Rise and Incomplete Fall of "Paracusis Willisii". Otol Neurotol. 2022 Jan 1;43(1):137-143. doi: 10.1097/MAO.0000000000003368.
- Background: PubMed 29661046Kelly EA, Li B, Adams ME. Diagnostic Accuracy of Tuning Fork Tests for Hearing Loss: A Systematic Review. Otolaryngol Head Neck Surg. 2018 Aug;159(2):220-230. doi: 10.1177/0194599818770405. Epub 2018 Apr 17.
- Background: PubMed 29397948Cheng HCS, Agrawal SK, Parnes LS. Stapedectomy Versus Stapedotomy. Otolaryngol Clin North Am. 2018 Apr;51(2):375-392. doi: 10.1016/j.otc.2017.11.008. Epub 2018 Feb 3.
- Background: PubMed 34267093Hoskison EE, Harrop E, Jufas N, Kong JHK, Patel NP, Saxby AJ. Endoscopic Stapedotomy: A Systematic Review. Otol Neurotol. 2021 Dec 1;42(10):e1638-e1643. doi: 10.1097/MAO.0000000000003242.
- Individual participant dataSharing planned: No
Related trials for Otosclerosis
Active, not recruiting
Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.
Otosclerosis, Cone Beam Computed Tomography
RecruitingObservational study
Investigating the Relationship Between Temporal Bone CT, Bone Density, and Hearing Loss in Otosclerosis Patients
Otosclerosis of Middle Ear, Bone Density
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.
Waleed Abdelhafeez, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endsocopic stapedotomy in people with Otosclerosis, run by Sohag 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 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 26 Dec 2025. 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 Mahmoud Sayed, specialist (+201028821440, mahmoud_sayed_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hearing level (time frame: 6 monthes). 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 NCT07304999, which also lists 4 linked publications.
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 26 Dec 2025.