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

Eustachian Tube Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02123277
• Other study ID #: 9259
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: December 2017

Study information

• Verified date: May 2018
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Eustachian Tube Disorder

Intervention

Device:
• Balloon catheter for the Eustachian tube
Balloon catheter is inserted in the Eustachian tube to dilate it.

Locations

Country	Name	City	State
France	Gui de Chauliac Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Tubal score		at 1st day, and 2 months