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Clinical Trials/DRKS00011088
DRKS00011088
Active, not recruiting
Phase 2

Comparative study of the therapeutic success of balloondilatation of the Eustachian tube with paracentesis vs. grommets in adult patients with chronic or recurrent otitis media with effusion - BETvs.Grommets

Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde,Kopf- und Halschirurgie Otto Körner0 sites6 target enrollmentSeptember 13, 2016
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ConditionsH65.3H69.8Chronic mucoid otitis mediaOther specified disorders of Eustachian tube

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
H65.3
Sponsor
Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde,Kopf- und Halschirurgie Otto Körner
Enrollment
6
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 13, 2016
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde,Kopf- und Halschirurgie Otto Körner

Eligibility Criteria

Inclusion Criteria

  • •effusion at least 6 weeks or minimum 3 times a year
  • •\- at least one paracentesis without improvement
  • •\- conservative treatment with topical steroids and valsalva at leat 4 weeks
  • •\- written consent
  • •\- min. 18 years old

Exclusion Criteria

  • •\- no visible orificeof the ET
  • •\- cleft palate
  • •\- lesions in the nasopharynx or suspicion of malignancy
  • •\- autoimmune disease
  • •\- status after radiation of head and neck region
  • •\- younger than 18 years
  • •\- no written consent

Outcomes

Primary Outcomes

Not specified

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