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

Not Applicable

Completed

• Conditions: Eustachian Tube Disorder
• Interventions: Device: Balloon catheter for the Eustachian tube

• Registration Number: NCT02123277
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-03-03
• Study First Submitted QC: 2014-04-23
• Study First Posted: 2014-04-25
• Study Start: 2014-05
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-18
• Last Update Posted: 2018-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
concept proof	Balloon catheter for the Eustachian tube	Balloon catheter for the Eustachian tube

Primary Outcome Measures

Name	Time	Method
Change in Tubal score	at 1st day, and 2 months

Trial Locations

Locations (1)

Gui de Chauliac Hospital; 🇫🇷 Montpellier, France