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Clinical Trials in Denmark / NCT05921578
Active, not recruiting Not applicable

Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.

NCT05921578 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Rigshospitalet
Phase
Not applicable
Started
2023-05-17
Last updated
2026-08-12

Condition(s) studied

OtosclerosisCone Beam Computed TomographyStapes Fixation

Investigational drug(s) / intervention(s)

Pre-operative planning based on CBCT

Pre-operative planning based on CBCT: Pre-operative planning based on CBCT

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adults (\>18 years of age). * Referred to our department suspected for otosclerosis. * Consents to participation in the project. Exclusion Criteria: * 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: Exclusion: \- Intraoperative findings not supporting otosclerosis.

Primary outcome measure(s)

  • Diagnostic precision of CBCT of the temporal bone in diagnosing otosclerosis. — 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 — Baseline
    The proportion of patients where CBCT assists in the decision clinical decision making of otosclerosis.
  • Prothesis placement (pre-operative planning) — 12 months
    Pre-operative CBCT based planning on the prothesis placement at surgery.
  • Post-operative follow-up: patient reported hearing — 12 months
    The effect of pre-operative planning on the patient reported hearing at follow-up.
  • Post-operative follow-up: measured hearing — 12 months
    The effect of pre-operative planning on the measured hearing (audiometry) at follow-up.

Trial sites (1)

FacilityCityRegionStatus
Rigshospitalet Copenhagen Denmark

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05921578 on ClinicalTrials.gov ↗ ← All trials in Denmark