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

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ClinicalTrials.gov Identifier: NCT02123277
Recruitment Status : Completed
First Posted : April 25, 2014
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Eustachian Tube Disorder Device: Balloon catheter for the Eustachian tube Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long Term Evaluation of Tubal Expansion on Obstructive Dysfunctions of Eustachian Tube
Study Start Date : May 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: concept proof
Balloon catheter for the Eustachian tube
Device: Balloon catheter for the Eustachian tube
Balloon catheter is inserted in the Eustachian tube to dilate it.




Primary Outcome Measures :
  1. Change in Tubal score [ Time Frame: at 1st day, and 2 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02123277


Locations
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France
Gui de Chauliac Hospital
Montpellier, France, 34090
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Frederic VENAIL CHRU Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02123277    
Other Study ID Numbers: 9259
First Posted: April 25, 2014    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018