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Completed

NCT Number: NCT02123277

Long Term Evaluation of Tubal Expansion on Obstructive Dysfunctions of Eustachian Tube

The study aim is to evaluate the tubal score on patients who suffer from obstructive dysfunction of eustachian tube before and after the eustachian tube dilatation.

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Key information

Conditions

Eustachian Tube Disorder

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gui de Chauliac Hospital

Montpellier, 34090, France

About this study

The study aim is to evaluate the tubal score on patients who suffer from obstructive dysfunction of eustachian tube before the intervention and 12 months after the eustachian tube dilatation.

This patients are refractory to the reference medical treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients between 20 and 80 years old
  • tubal score lower than 5
  • patients who already used reference medical treatment

Exclusion criteria

  • patients who already do a major surgery of middle ear
  • tympanic perforation
  • pregnant or breastfeeding woman.
  • patients who can't be follow during 14 months

Treatment and study plan

Balloon catheter for the Eustachian tube

Device

Balloon catheter is inserted in the Eustachian tube to dilate it.

Primary outcomes

  1. Change in Tubal score

    Time frame: at 1st day, and 2 months

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 25, 2014
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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