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Balloon Dilation in Selected Subjects With Refractory Eustachian Tube Dysfunction

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ClinicalTrials.gov Identifier: NCT02114762
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : September 11, 2017
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Cuneyt M. Alper, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE April 7, 2014
First Posted Date  ICMJE April 15, 2014
Last Update Posted Date September 11, 2017
Actual Study Start Date  ICMJE April 2014
Actual Primary Completion Date November 23, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2017)
Eustachian tube function testing [ Time Frame: 1 month post-operatively ]
opening pressure, closing pressure, passive resistance
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2014)
Eustachian tube function testing [ Time Frame: 1 month post-operatively ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2017)
  • Eustachian tube function testing [ Time Frame: 3 months post-operatively ]
    opening pressure, closing pressure, passive resistance
  • Eustachian tube function testing [ Time Frame: 6 months post-operatively ]
    opening pressure, closing pressure, passive resistance
  • Eustachian tube function testing [ Time Frame: 4 weeks after beginning medical treatment ]
    opening pressure, closing pressure, passive resistance
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2014)
  • Eustachian tube function testing [ Time Frame: 3 months post-operatively ]
  • Eustachian tube function testing [ Time Frame: 6 months post-operatively ]
  • Eustachian tube function testing [ Time Frame: 4 weeks after beginning medical treatment ]
Current Other Pre-specified Outcome Measures
 (submitted: April 10, 2014)
video-endoscopy [ Time Frame: entry visit ]
ability of video-endoscopy to diagnose anatomic cause of eustachian tube dysfunction
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Balloon Dilation in Selected Subjects With Refractory Eustachian Tube Dysfunction
Official Title  ICMJE Balloon Dilation in Selected Subjects With Refractory Eustachian Tube Dysfunction
Brief Summary This study evaluates the usefulness and safety of using a balloon to dilate (make larger) the Eustachian tube in adults who have middle-ear disease due to Eustachian tube dysfunction.
Detailed Description

The Eustachian tube is a biological tube that connects the back of the nose to the middle ear. It is usually closed but needs to be actively opened by the action of certain muscles during swallowing, yawning, and other activities which keeps the air pressure in the middle ear (the part of the ear behind the eardrum) the same as the air pressure in the environment. If the Eustachian tube does not open during swallowing, the middle-ear pressure progressively decreases and persons may have the feeling of a "stuffed up" and/or "full" middle ear, may have difficulty hearing and/or may develop fluid in their middle ear.

The usual treatment for a Eustachian tube that does not open well is to insert a tiny tube (called a ventilation or tympanostomy tube) into the eardrum to keep the air pressure in the middle ear the same as in the environment. However, those tubes naturally "fall out" over time, and if the Eustachian tube opening function had not improved while they were in place, new tubes will need to be inserted. In the past few years, doctors in the U.S. and Europe described a simple procedure called "balloon dilation of the Eustachian tube" (BDET) or "balloon tuboplasty" that they believe corrects the underlying cause of Eustachian tube dysfunction and resolves its symptoms, signs and consequences. For that procedure, a tiny balloon is inserted into the Eustachian tube, inflated to physically open the Eustachian tube, deflated and then removed. Doctors who have used the method in adults and children with symptoms of Eustachian tube dysfunction reported that BDET is safe and causes a short-term and, perhaps, a long-term resolution of symptoms. However, no one has measured Eustachian tube function before and after the procedure, and it is not known if BDET truly improves that function or not, and if so, how that function is changed.

In this study, we will enroll adult subjects with a tympanostomy tube inserted into at least one eardrum or a chronic perforation in at least one eardrum for physician-diagnosed Eustachian tube dysfunction or middle-ear fluid and document the presence/absence of measurable Eustachian tube dysfunction using standard tests. If present, we will determine if the Eustachian tube dysfunction improves after medical treatment of other diseases known to cause Eustachian tube dysfunction. If the Eustachian tube dysfunction does not significantly improve, we will perform the BDET procedure and measure the change in Eustachian tube function at different times after the procedure.

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 Dysfunction
Intervention  ICMJE Procedure: Balloon dilation of the Eustachian tube
Insert a balloon into one Eaustachian tube and inflate it for up to one minute. The balloon is then removed.
Other Name: Balloon tuboplasty
Study Arms  ICMJE Experimental: Balloon dilation of the Eustachian tube
Insertion and inflation of balloon into Eustachian tube for up to 1 minute
Intervention: Procedure: Balloon dilation of 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: November 2, 2016)
13
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2014)
80
Actual Study Completion Date  ICMJE April 30, 2017
Actual Primary Completion Date November 23, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • has functional ventilation tube or a chronic perforation in at least one ear;
  • history of Eustachian tube dysfunction and/or otitis media with effusion;
  • history of middle-ear effusion at least once;
  • otherwise healthy except for possible gastro-esophageal reflux disease (GERD), allergies, sinusitis;
  • BMI of less than 35;
  • no history of difficult intubation;
  • no known family history of malignant hyperthermia.

Exclusion Criteria:

  • history of adverse reaction to any study-related medication and a suitable alternative is not available;
  • current or past history of cancer;
  • current or past history of vestibular pathology or cranial base surgery;
  • craniofacial dysmorphology (examples: down syndrome, cleft palate);
  • pregnancy or "at risk" and not using contraception;
  • patulous Eustachian tube;
  • non-patent nasal cavity;
  • adenoids that block the Eustachian tube orifice;
  • blood pressure greater than 140/90;
  • had experimental drug or procedure in the previous 3 months;
  • allergic to eggs, egg products, soy, or soy products;
  • previously underwent balloon dilation of the Eustachian tube.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02114762
Other Study ID Numbers  ICMJE PRO13120437
R21DC013167 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cuneyt M. Alper, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators  ICMJE
Principal Investigator: Cuneyt M Alper, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date September 2017

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