NCT02114762

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

2.6 years

First QC Date

April 7, 2014

Last Update Submit

September 6, 2017

Conditions

Eustachian Tube Dysfunction

Keywords

otitis mediaeustachian tubeeustachian tube dysfunctioneustachian tube function testing

Outcome Measures

Primary Outcomes (1)

  • Eustachian tube function testing

    opening pressure, closing pressure, passive resistance

    1 month post-operatively

Secondary Outcomes (3)

  • Eustachian tube function testing

    3 months post-operatively

  • Eustachian tube function testing

    6 months post-operatively

  • Eustachian tube function testing

    4 weeks after beginning medical treatment

Other Outcomes (1)

  • video-endoscopy

    entry visit

Study Arms (1)

Balloon dilation of the Eustachian tube

EXPERIMENTAL

Insertion and inflation of balloon into Eustachian tube for up to 1 minute

Procedure: Balloon dilation of the Eustachian tube

Interventions

Balloon dilation of the Eustachian tubePROCEDURE

Insert a balloon into one Eaustachian tube and inflate it for up to one minute. The balloon is then removed.

Also known as: Balloon tuboplasty
Balloon dilation of the Eustachian tube

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Swords C, Smith ME, Patel A, Norman G, Llewellyn A, Tysome JR. Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults. Cochrane Database Syst Rev. 2025 Feb 26;2(2):CD013429. doi: 10.1002/14651858.CD013429.pub2.

    PMID: 40008607DERIVED

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Cuneyt M Alper, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Otolaryngology

Study Record Dates

First Submitted

April 7, 2014

First Posted

April 15, 2014

Study Start

April 1, 2014

Primary Completion

November 23, 2016

Study Completion

April 30, 2017

Last Updated

September 11, 2017

Record last verified: 2017-09

Locations

US(1)