RecruitingNot Applicable

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

Denmark100 participantsStarted 2023-05-17

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Diagnostic precision of CBCT of the temporal bone in diagnosing otosclerosis.

Timeframe: Per-operative

Clinical decision-making in the diagnosis of suspected otosclerosis

Timeframe: Baseline

Prothesis placement (pre-operative planning)

Timeframe: 12 months

Post-operative follow-up: patient reported hearing

Timeframe: 12 months

Post-operative follow-up: measured hearing

Timeframe: 12 months

Trial details

NCT IDNCT05921578

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Bilal H Akram

+4535451973 bilal.hussain.akram@regionh.dk

View on ClinicalTrials.gov More Otosclerosis trials