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

University Hospital Center (CHU)

Status: Completed

Conditions: Eustachian Tube Disorder

Treatments: Device: Balloon catheter for the Eustachian tube

Study type: Interventional

Funder types: Other

Identifiers

NCT02123277

9259

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

concept proof

Experimental group

Description:

Balloon catheter for the Eustachian tube

Treatment:

Device: Balloon catheter for the Eustachian tube