OtosclerosisNCT05921578
Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.
A study testing Pre-operative planning based on CBCT in people with Otosclerosis and Cone Beam Computed Tomography, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Our studies will systematically investigate and establish evidence on whether Cone-beam computed tomography (CBCT) of the temporal bone could be used in the diagnosis and treatment of otosclerosis and in the post-operative follow-up after stapedotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Otosclerosis, Cone Beam Computed Tomography, Stapes Fixation
- What is being tested?
- Pre-operative planning based on CBCT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 17 May 2023to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (>18 years of age).
- Referred to our department suspected for otosclerosis.
- Consents to participation in the project.
Who cannot join
- A history of surgical treatment for otosclerosis (ipsilateral ear).
- A history of tympanoplasty type 2-4 (ipsilateral ear).
- Other competing middle-ear diseases (ipsilateral ear).
- Inclusion and exclusion criteria for patients enrolled for post-surgical follow-up are the same as above in addition to:
- Intraoperative findings not supporting otosclerosis.
Trial locations and contacts
1 site in 1 country.
About this study
Our studies will systematically investigate and establish evidence on whether Cone-beam computed tomography (CBCT) of the temporal bone could be used in the diagnosis and treatment of otosclerosis and in the post-operative follow-up after stapedotomy.
Read the detailed description
Cone-beam CT has a high resolution and a low effective radiation dose to the patient when compared to conventional CT-scans. Surgical treatment of otosclerosis is primarily by stapedotomy. The decision of surgical treatment is currently based on the history, clinical examination, and audiological tests, but stapes fixation can only be confirmed per-operatively.
This protocol includes the following overall aims for the following studies:
- To establish the diagnostic precision of clinical CBCT in diagnosing otoslcerosis, i.e., the sensibility and specificity for our scanning protocols (n=50).
- To determine if CBCT can support the clinicians' decision making in the diagnosis of otosclerosis (n=100).
- To assess the value of CBCT in the planning of stapes surgery. Two groups will be established: CBCT-based pre-operative planning (e.g., prothesis parameters and anatomic landmarks) and no-planning (standard treatment). Patients will be allocated by 1:1 randomization (n=75).
- To assess the value of CBCT in the post-operative follow-up of 2-3 weeks, 2-3 months, and 12 months. Follow-up includes a clinical examination, audiometry, CBCT (block-randomized), and patient questionnaires (audiometry and patient questionnaire not at the "2-3 weeks" control) (n=75).
- To assess the value of pre-preoperative CBCT on post-surgical result at follow up (2-3 weeks, 2-3, months and 12-months) (n=75).
- Conditions
- Otosclerosis, Cone Beam Computed Tomography, Stapes Fixation
- Being tested
- Pre-operative planning based on CBCT
- Keywords
- otosclerosis, stapedotomy, cone beam CT
- Medical subject headings
- Otosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative planning based on CBCTDiagnostic test
Pre-operative planning based on CBCT
| Study group | Role | What they receive |
|---|---|---|
| Routine diagnostic workup | No intervention | Not described |
| Routine diagnostic workup + pre-operative CBCT-based planning | Experimental | Not described Receives: Diagnostic Test: Pre-operative planning based on CBCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic precision of CBCT of the temporal bone in diagnosing otosclerosis.
The diagnostic precision will be established, i.e., the sensibility and specificity for our scanning protocols.
Measured: Per-operative
Clinical decision-making in the diagnosis of suspected otosclerosis
The proportion of patients where CBCT assists in the decision clinical decision making of otosclerosis.
Measured: Baseline
Prothesis placement (pre-operative planning)
Pre-operative CBCT based planning on the prothesis placement at surgery.
Measured: 12 months
Post-operative follow-up: patient reported hearing
The effect of pre-operative planning on the patient reported hearing at follow-up.
Measured: 12 months
Post-operative follow-up: measured hearing
The effect of pre-operative planning on the measured hearing (audiometry) at follow-up.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start17 May 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OtosclerosisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Andersen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921578
- Sponsor's protocol ID
- H-22067452
- Status last verified
- Aug 2026
- First submitted
- 6 Jun 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.
- ClinicalTrials.gov ID
- NCT05921578
- Acronym / sponsor ID
- H-22067452
- Conditions
- Otosclerosis, Cone Beam Computed Tomography, Stapes Fixation
- Keywords
- otosclerosis, stapedotomy, cone beam CT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 17 May 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Jun 2023 (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.
Our studies will systematically investigate and establish evidence on whether Cone-beam computed tomography (CBCT) of the temporal bone could be used in the diagnosis and treatment of otosclerosis and in the post-operative follow-up after stapedotomy.
Detailed description
Cone-beam CT has a high resolution and a low effective radiation dose to the patient when compared to conventional CT-scans. Surgical treatment of otosclerosis is primarily by stapedotomy. The decision of surgical treatment is currently based on the history, clinical examination, and audiological tests, but stapes fixation can only be confirmed per-operatively.
This protocol includes the following overall aims for the following studies:
- To establish the diagnostic precision of clinical CBCT in diagnosing otoslcerosis, i.e., the sensibility and specificity for our scanning protocols (n=50).
- To determine if CBCT can support the clinicians' decision making in the diagnosis of otosclerosis (n=100).
- To assess the value of CBCT in the planning of stapes surgery. Two groups will be established: CBCT-based pre-operative planning (e.g., prothesis parameters and anatomic landmarks) and no-planning (standard treatment). Patients will be allocated by 1:1 randomization (n=75).
- To assess the value of CBCT in the post-operative follow-up of 2-3 weeks, 2-3 months, and 12 months. Follow-up includes a clinical examination, audiometry, CBCT (block-randomized), and patient questionnaires (audiometry and patient questionnaire not at the "2-3 weeks" control) (n=75).
- To assess the value of pre-preoperative CBCT on post-surgical result at follow up (2-3 weeks, 2-3, months and 12-months) (n=75).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine diagnostic workup | No intervention | – |
| Routine diagnostic workup + pre-operative CBCT-based planning | Experimental | Diagnostic Test: Pre-operative planning based on CBCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (>18 years of age).
- Referred to our department suspected for otosclerosis.
- Consents to participation in the project.
Key exclusion criteria (5 listed)
- A history of surgical treatment for otosclerosis (ipsilateral ear).
- A history of tympanoplasty type 2-4 (ipsilateral ear).
- Other competing middle-ear diseases (ipsilateral ear).
- Inclusion and exclusion criteria for patients enrolled for post-surgical follow-up are the same as above in addition to:
- Intraoperative findings not supporting otosclerosis.
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 |
|---|---|---|
| Pre-operative planning based on CBCTPre-operative planning based on CBCT | Diagnostic test | Routine diagnostic workup + pre-operative CBCT-based planning |
Primary outcome
Diagnostic precision of CBCT of the temporal bone in diagnosing otosclerosis.
Time frame: Per-operative
The diagnostic precision will be established, i.e., the sensibility and specificity for our scanning protocols.
Clinical decision-making in the diagnosis of suspected otosclerosis
Time frame: Baseline
The proportion of patients where CBCT assists in the decision clinical decision making of otosclerosis.
Prothesis placement (pre-operative planning)
Time frame: 12 months
Pre-operative CBCT based planning on the prothesis placement at surgery.
Post-operative follow-up: patient reported hearing
Time frame: 12 months
The effect of pre-operative planning on the patient reported hearing at follow-up.
Post-operative follow-up: measured hearing
Time frame: 12 months
The effect of pre-operative planning on the measured hearing (audiometry) at follow-up.
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 12 Aug 2026.
Related trials for Otosclerosis
Not yet recruiting
Surgical and Audiological Outcomes of Endoscopic Stapes Surgery
Otosclerosis
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. 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?
A study testing Pre-operative planning based on CBCT in people with Otosclerosis and Cone Beam Computed Tomography, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 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 Denmark. 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?
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?
Diagnostic precision of CBCT of the temporal bone in diagnosing otosclerosis. (time frame: Per-operative). The study lists 5 primary outcomes in all. 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 12 Aug 2026.