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Balloon Dilation in Selected Subjects With Refractory Eustachian Tube Dysfunction

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cuneyt M. Alper, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02114762
First received: April 7, 2014
Last updated: October 28, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Eustachian Tube Dysfunction
Procedure: Balloon dilation of the Eustachian tube
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Balloon Dilation in Selected Subjects With Refractory Eustachian Tube Dysfunction

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Eustachian tube function testing [ Time Frame: 1 month post-operatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Eustachian tube function testing [ Time Frame: 3 months post-operatively ] [ Designated as safety issue: Yes ]
  • Eustachian tube function testing [ Time Frame: 6 months post-operatively ] [ Designated as safety issue: Yes ]
  • Eustachian tube function testing [ Time Frame: 4 weeks after beginning medical treatment ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • video-endoscopy [ Time Frame: entry visit ] [ Designated as safety issue: No ]
    ability of video-endoscopy to diagnose anatomic cause of eustachian tube dysfunction


Estimated Enrollment: 80
Study Start Date: April 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Balloon tuboplasty

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • has functional ventilation tube 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02114762

Contacts
Contact: Jenna El-Wagaa 412-692-3595
Contact: Julie Banks, BS 412-692-3595

Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Cuneyt M Alper, MS         
Sub-Investigator: William J Doyle, PhD         
Sub-Investigator: Miriam S Teixeira, MD         
Sub-Investigator: Tanya Rath, MD         
Sub-Investigator: Denise Hall-Burton, MD         
Sub-Investigator: Ellen M Mandel, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Cuneyt M Alper, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Cuneyt M. Alper, Professor of Otolaryngology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02114762     History of Changes
Other Study ID Numbers: PRO13120437
Study First Received: April 7, 2014
Last Updated: October 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
otitis media
eustachian tube
eustachian tube dysfunction
eustachian tube function testing

ClinicalTrials.gov processed this record on November 24, 2014