Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
France
Gui de Chauliac Hospital
Montpellier, France, 34090
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Layout table for investigator information
Principal Investigator: Frederic VENAIL CHRU Montpellier
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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