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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

Tracking Information
First Submitted Date  ICMJE March 3, 2014
First Posted Date  ICMJE April 25, 2014
Last Update Posted Date May 22, 2018
Study Start Date  ICMJE May 2014
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2014)
Change in Tubal score [ Time Frame: at 1st day, and 2 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long Term Evaluation of Tubal Expansion on Obstructive Dysfunctions of Eustachian Tube
Official Title  ICMJE Long Term Evaluation of Tubal Expansion on Obstructive Dysfunctions of Eustachian Tube
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Eustachian Tube Disorder
Intervention  ICMJE Device: Balloon catheter for the Eustachian tube
Balloon catheter is inserted in the Eustachian tube to dilate it.
Study Arms  ICMJE Experimental: concept proof
Balloon catheter for the Eustachian tube
Intervention: Device: Balloon catheter for the Eustachian tube
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2018)
31
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2014)
30
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02123277
Other Study ID Numbers  ICMJE 9259
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frederic VENAIL CHRU Montpellier
PRS Account University Hospital, Montpellier
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP