NCT04136977

Brief Summary

A prospective, multicenter, registry of patients undergoing balloon dilation of the Eustachian tubes (ET).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
169

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

11 active sites

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

June 5, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2020

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

2.2 years

First QC Date

October 2, 2019

Last Update Submit

September 29, 2020

Conditions

Eustachian Tube Dysfunction

Outcome Measures

Primary Outcomes (2)

  • Change in mean Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score

    Change from baseline to follow-up in the mean overall ETDQ-7 score. The ETDQ-7 is a validated 7-item patient-reported questionnaire reporting the presence and severity of symptoms associated with Eustachian tube dysfunction. Each item is scored from 1 (normal) to 7 (severe). The overall score is the mean score of the 7 items.

    6 Months

  • Complication rate

    Percentage of participants who experience 1 or more serious adverse events that are related to the device and/or procedure.

    6 Months

Secondary Outcomes (10)

  • Procedural information

    Procedure through 6-week follow-up

  • Minimal clinically important difference in ETDQ-7 score

    6 Months

  • Revision Eustachian tube dilation

    6 Months

  • Surgical interventions

    6 Months

  • Participant satisfaction: Proportion of participants indicating satisfaction and willing to recommend the procedure to friends or family

    6 Months

  • +5 more secondary outcomes

Interventions

Eustachian tube dilationDEVICE

Unilateral or bilateral balloon dilation of the Eustachian tube using the FDA-cleared XprESS ENT Dilation System

Also known as: XprESS ET balloon dilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with persistent/chronic Eustachian tube dysfunction who are undergoing balloon dilation of the Eustachian tubes.

You may qualify if:

  • Be at least 18 years old
  • Have been diagnosed with persistent/chronic Eustachian tube dysfunction (duration 3 months or more)
  • Be a candidate for unilateral or bilateral Eustachian tube balloon dilation using the XprESS device
  • Be able to read and understand English
  • Be willing and able to provide informed consent
  • Be willing to comply with the protocol requirements

You may not qualify if:

  • Have a history of patulous Eustachian tube
  • Require additional ear surgery (eg, myringotomy, tympanostomy) at the time of study procedure
  • Have evidence of internal carotid artery dehiscence
  • Be currently participating in any other drug or device clinical studies, excluding postapproval or marketing registry studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Breathe Clear Institute

Torrance, California, 90503, United States

Location

Colorado ENT and Allergy

Colorado Springs, Colorado, 80909, United States

Location

Augusta ENT and Allergy

Evans, Georgia, 30809, United States

Location

St. Vincent Anderson Hospital

Anderson, Indiana, 46016, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Ear Nose and Throat Consultants

Southfield, Michigan, 48934, United States

Location

St Cloud ENT

Saint Cloud, Minnesota, 56303, United States

Location

ENT Consultants of Nevada

Las Vegas, Nevada, 89128, United States

Location

Lakeside ENT

Canandaigua, New York, 14424, United States

Location

National Allergy and ENT

Charleston, South Carolina, 29420, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, 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

Study Officials

  • Edward D McCoul, MD, PhD

    Ochsner Health System, New Orleans, LA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2019

First Posted

October 23, 2019

Study Start

June 5, 2018

Primary Completion

August 28, 2020

Study Completion

August 28, 2020

Last Updated

September 30, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(11)