NCT02391584

Brief Summary

Study to assess the safety and efficacy of the XprESS device for transnasal Eustachian tube dilation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
1 country

5 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

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 9, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 1, 2018

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

2.1 years

First QC Date

March 9, 2015

Results QC Date

July 10, 2018

Last Update Submit

October 1, 2018

Conditions

Eustachian Tube Dysfunction

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline in Mean Overall ETDQ-7 Scores

    Comparison of mean change in overall ETDQ-7 scores from baseline to 6 weeks between randomized arms. The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) is a validated patient-reported tool measuring ETD symptoms and severity. The 7 items are: pressure in the ears, pain in the ears, a feeling that your ears are clogged or underwater, ear symptoms when you have a cold of sinusitis, cracking or popping sounds in the ear, ringing in the ears, and a feeling that your hearing is muffled. Each item is rated from 1 (no problem) to 7 (severe problem) and a mean is calculated for the overall score (range from 1-7). Scores of 1-2 indicate no to mild symptoms, 3-5 moderate, and 6-7 severe symptoms.

    6 weeks post procedure (treatment arm) or randomization (control arm)

  • Complication Rate

    Number of subjects who experience serious device- or procedure-related adverse events

    Through 6 months post-procedure

Secondary Outcomes (6)

  • Technical Success Rate

    Immediately after procedure

  • Revision Rate

    12 months

  • Mean Change in Overall ETDQ-7 Score

    12 months postdilation

  • Mean Change in Overall ETDQ-7 Score

    6 months postdilation

  • Mean Change in Overall ETDQ-7 Score

    3 months postdilation

  • +1 more secondary outcomes

Study Arms (2)

XprESS

EXPERIMENTAL

Balloon dilation of the Eustachian tube

Device: XprESS

Control

OTHER

Continued medical management

Other: Control

Interventions

XprESSDEVICE

Balloon dilation of the Eustachian tube

XprESS
ControlOTHER

Continued medical management

Also known as: Continued medical management
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥18 years old
  • Have been diagnosed with symptoms of chronic Eustachian tube dysfunction for no less than 12 months prior to enrollment
  • Have an overall ETDQ-7 score ≥3.0
  • Have record of failed medical management for Eustachian tube dysfunction

You may not qualify if:

  • Require concomitant procedures at the time of the study enrollment or procedure
  • Have patulous Eustachian tube
  • Have ear tubes in place or perforation of the tympanic membrane
  • Have evidence of internal carotid artery dehiscence
  • Be pregnant at the time of enrollment
  • Be currently participating in other drug or device studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Colorado Sinus Institute

Denver, Colorado, 80210, United States

Location

Ear Nose Throat and Sinus Clinic

North Platte, Nebraska, 69101, United States

Location

Donald Guthrie Foundation

Sayre, Pennsylvania, 18840, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Austin Ear Clinic

Austin, Texas, 78758, United States

Location

Related Publications (2)

  • Meyer TA, O'Malley EM, Schlosser RJ, Soler ZM, Cai J, Hoy MJ, Slater PW, Cutler JL, Simpson RJ, Clark MJ, Rizk HG, McRackan TR, D'Esposito CF, Nguyen SA. A Randomized Controlled Trial of Balloon Dilation as a Treatment for Persistent Eustachian Tube Dysfunction With 1-Year Follow-Up. Otol Neurotol. 2018 Aug;39(7):894-902. doi: 10.1097/MAO.0000000000001853.

    PMID: 29912819RESULT

  • 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

Results Point of Contact

Title
Clinical Affairs Manager
Organization
Entellus Medical
rschacherer@entellusmedical.com
7634631595

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 18, 2015

Study Start

February 1, 2015

Primary Completion

March 1, 2017

Study Completion

October 1, 2017

Last Updated

November 1, 2018

Results First Posted

November 1, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(5)