Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 17, 2023
CompletedFirst Submitted
Initial submission to the registry
June 6, 2023
CompletedFirst Posted
Study publicly available on registry
June 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedApril 4, 2025
April 1, 2025
2.5 years
June 6, 2023
April 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
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.
Baseline
Prothesis placement (pre-operative planning)
Pre-operative CBCT based planning on the prothesis placement at surgery.
12 months
Post-operative follow-up: patient reported hearing
The effect of pre-operative planning on the patient reported hearing at follow-up.
12 months
Post-operative follow-up: measured hearing
The effect of pre-operative planning on the measured hearing (audiometry) at follow-up.
12 months
Study Arms (2)
Routine diagnostic workup
NO INTERVENTIONRoutine diagnostic workup + pre-operative CBCT-based planning
EXPERIMENTALInterventions
Pre-operative planning based on CBCT
Eligibility Criteria
You may qualify if:
- Adults (\>18 years of age).
- Referred to our department suspected for otosclerosis.
- Consents to participation in the project.
You may not qualify if:
- 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).
- \- Intraoperative findings not supporting otosclerosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rigshospitalet
Copenhagen, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., PhD, Senior Researcher
Study Record Dates
First Submitted
June 6, 2023
First Posted
June 27, 2023
Study Start
May 17, 2023
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
April 4, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share