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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02123277

Enrollment

Registered

2014-04-25

Start date

2014-05-01

Completion date

2017-12-01

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eustachian Tube Disorder

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.

Interventions

DEVICEBalloon catheter for the Eustachian tube

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Change in Tubal score	at 1st day, and 2 months

Countries

France

Contacts

PRINCIPAL_INVESTIGATORFrederic VENAIL

CHRU Montpellier

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026