Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.
NCT ID: NCT05921578
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
100 participants
INTERVENTIONAL
2023-05-17
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cone Beam vs MDCT for Diagnosis and Pre-operative Evaluation of Otosclerosis
NCT05214053
Cone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose
NCT01855425
Quantification of Prosthesis Penetration With Conebeam in Otosclerosis
NCT02901093
Cone Beam CT Versus Multislice CT in the Postoperative Assessment of Cochlear Implantation
NCT02892552
Stapes Footplate Thickness Measured With UHR-CT
NCT05799404
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Routine diagnostic workup
No interventions assigned to this group
Routine diagnostic workup + pre-operative CBCT-based planning
Pre-operative planning based on CBCT
Pre-operative planning based on CBCT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pre-operative planning based on CBCT
Pre-operative planning based on CBCT
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Referred to our department suspected for otosclerosis.
* Consents to participation in the project.
Exclusion Criteria
* A history of tympanoplasty type 2-4 (ipsilateral ear).
* Other competing middle-ear diseases (ipsilateral ear).
Exclusion:
\- Intraoperative findings not supporting otosclerosis.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rigshospitalet, Denmark
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Steven Andersen
M.D., PhD, Senior Researcher
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rigshospitalet
Copenhagen, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-22067452
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.