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
|Condition or disease||Intervention/treatment||Phase|
|Eustachian Tube Dysfunction||Procedure: Balloon dilation of the Eustachian tube||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Balloon Dilation in Selected Subjects With Refractory Eustachian Tube Dysfunction|
|Actual Study Start Date :||April 2014|
|Actual Primary Completion Date :||November 23, 2016|
|Actual Study Completion Date :||April 30, 2017|
Experimental: Balloon dilation of the Eustachian tube
Insertion and inflation of balloon into Eustachian tube for up to 1 minute
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
- Eustachian tube function testing [ Time Frame: 1 month post-operatively ]opening pressure, closing pressure, passive resistance
- 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
- video-endoscopy [ Time Frame: entry visit ]ability of video-endoscopy to diagnose anatomic cause of eustachian tube dysfunction
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): NCT02114762
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh of UPMC|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Cuneyt M Alper, MD||University of Pittsburgh|