Using Cone-beam CT to Diagnose and Treat Otosclerosis
Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.
This study is testing if using a special type of 3D imaging called Cone-beam CT can help doctors diagnose otosclerosis and plan surgery better than the usual methods for patients needing treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05921578 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of Cone-beam computed tomography (CBCT) for diagnosing otosclerosis and planning surgical treatment through stapedotomy. It aims to establish the diagnostic precision of CBCT, assess its role in clinical decision-making, and evaluate its effectiveness in pre-operative planning and post-operative follow-up. The study will involve randomization of patients into groups receiving CBCT-based planning versus standard treatment, with follow-up assessments at various intervals. A total of 300 patients will be included across different phases of the study.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years suspected of having otosclerosis who consent to participate.
Not a fit: Patients with a history of surgical treatment for otosclerosis or other middle-ear diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses and improved surgical outcomes for patients with otosclerosis.
How similar studies have performed: While the use of CBCT in otosclerosis is a relatively novel approach, similar imaging techniques have shown promise in other surgical fields.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Copenhagen
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Bilal H Akram
- Email: bilal.hussain.akram@regionh.dk
- Phone: +4535451973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.