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NCT03440710

The Therapeutic Effect of BET in COM With ETD

Status unknown NA Last updated 22 February 2018
What this trial tests

NA trial testing BET in Balloon Eustachian Tuboplasty in 60 participants. Status unknown.

Timeline
1 June 2018
Primary endpoint
30 May 2019
30 December 2019

Quick facts

Lead sponsorEye & ENT Hospital of Fudan University
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment60
Start date1 June 2018
Primary completion30 May 2019
Estimated completion30 December 2019
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Eye & ENT Hospital of Fudan University

Who can join

Adults 18 to 75, any sex, with Balloon Eustachian Tuboplasty. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Currently, surgical treatment of patients with chronic otitis media is one of the most important treatment methods. However, the current results show that some patients with eustachian tube dysfunction can't reconstruct the gas-containing structure of the middle ear after operation. This is a randomized controlled trial that aims to evaluate the therapeutic effect of balloon eustachian tuboplasty (BET) for the treatment in chronic otitis media (COM) with eustachian tube dysfunction (ETD). This future study will aim to address the question: Does BET gain better recovery of auditory function and lower recurrence rate in chronic otitis media with eustachian tube dysfunction?

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults.
    Swords C, Smith ME, Patel A, Norman G, et al · · 2025 · cited 2× · PMID 40008607 · DOI 10.1002/14651858.cd013429.pub2

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Trials by the same sponsor.

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