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NCT03556215
Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction
NA trial testing Eustachian tube dilatation device in Chronic Eustachian Tube Dysfunction in 55 participants. Completed in 30 November 2020.
31 May 2020
Quick facts
| Lead sponsor | University Hospital Ostrava |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 55 |
| Start date | 1 May 2016 |
| Primary completion | 31 May 2020 |
| Estimated completion | 30 November 2020 |
| Sites | 2 locations across Czechia |
Drugs / interventions tested
- Eustachian tube dilatation device
- Myringotomy
Conditions studied
- Chronic Eustachian Tube Dysfunction — all drugs for Chronic Eustachian Tube Dysfunction →
- Chronic Recurrent Otitis Media — all drugs for Chronic Recurrent Otitis Media →
- Effusion After Tympanostomy — all drugs for Effusion After Tympanostomy →
Sponsor
University Hospital Ostrava
Who can join
Adults 18 to 99, any sex, with Chronic Eustachian Tube Dysfunction or Chronic Recurrent Otitis Media. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The prevalence of Eustachian tube (ET) dysfunction in adults reaches 1%. It causes a feeling of fullness in the ear, otalgia and hearing loss and can lead to recurrent acute otitis media, development of chronic otitis media with effusion and cholesteatoma. Endoscopic transnasal balloon ET dilatation is a novel surgical technique for ET dysfunction. The main goal is to restore ET function by dilation its cartilaginous part leading to better ventilation and drainage of the middle ear. However, its real effect in the treatment of particular subgroups of patients with ET dysfunction remains unknown. Patients are mostly evaluated as one group. Adults with chronic ET dysfunction will be strictly divided into particular subgroups and included in the study. Subgroups will be compared in order to identify treatment effect in particular subgroups.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03556215
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03556215 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital Ostrava
- Last refreshed: 7 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03556215.
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