Balloon Dilation in Selected Subjects With Refractory Eustachian Tube Dysfunction
Condition: Eustachian Tube Dysfunction
MeSH terms: Dilatation, Pathologic
Study type: Interventional

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.
    

Intervention name(s): Balloon dilation of the Eustachian tube
Intervention type(s): Procedure
Intervention description(s): Insert a balloon into one Eaustachian tube and inflate it for up to one minute. The balloon is then removed.
Other intervention name(s): Balloon tuboplasty
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: otitis media; eustachian tube; eustachian tube dysfunction; eustachian tube function testing