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Clinical Trials/ISRCTN50406162
ISRCTN50406162
Completed
未知

Efficacy of balloon Eustachian tuboplasty - prospective, blinded and placebo-controlled multi-centre study

Helsinki University Hospital0 sites165 target enrollmentNovember 23, 2017
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ConditionsPersistent secretory otitis media, severe symptoms of ETD or baro-challenged ETDEar, Nose and ThroatNonsuppurative otitis media, unspecifiedother disorders of Eustachian tube

Overview

Phase
未知
Intervention
Not specified
Conditions
Persistent secretory otitis media, severe symptoms of ETD or baro-challenged ETD
Sponsor
Helsinki University Hospital
Enrollment
165
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 23, 2017
End Date
May 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Helsinki University Hospital

Eligibility Criteria

Inclusion Criteria

  • •All patients in this study suffer from dilatory Eustachian tube dysfunction and are deemed suitable for BET. Possible indications are:
  • •1\. Persistent secretory otitis media
  • •2\. Severe symptoms of ETD
  • •3\. Baro\-challenged ETD

Exclusion Criteria

  • •1\. The occurrence of cleft palate in any form
  • •2\. Current ventilating grommet
  • •3\. Tympanic membrane perforation
  • •4\. Adhesive otitis
  • •5\. Cholesteatoma
  • •6\. Cystic fibrosis
  • •7\. Immotile cilia syndrome
  • •8\. Untreated nasal polyposis
  • •9\. Samter's triade
  • •10\. Untreated gastroesophageal reflux disease

Outcomes

Primary Outcomes

Not specified

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