Balloon Dilation in Selected Subjects With Refractory Eustachian Tube Dysfunction

Completed · Not applicable

Conditions studied: Eustachian Tube Dysfunction

In brief

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.

Key facts

Study ID: NCT02114762
Run by: University of Pittsburgh
People needed: 13
Starts: 2014-04-01
Expected to finish: 2017-04-30
Last updated by the study team: 2017-09-11

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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