XprESS Eustachian Tube Dilation Study

Eustachian Tube Dysfunction Clinical Trial

Official title:

XprESS Eustachian Tube Dilation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391584
• Other study ID #: 2909-001
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: October 2017

Study information

• Verified date: October 2018
• Source: Entellus Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Prospective, multicenter, randomized controlled trial comparing balloon dilation of the Eustachian tube to continued medical management for treatment of persistent Eustachian tube dysfunction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Eustachian Tube Dysfunction

Intervention

Device:
• XprESS
Balloon dilation of the Eustachian tube

Other:
• Control
Continued medical management

Locations

Country	Name	City	State
United States	Austin Ear Clinic	Austin	Texas
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Colorado Sinus Institute	Denver	Colorado
United States	Ear Nose Throat and Sinus Clinic	North Platte	Nebraska
United States	Donald Guthrie Foundation	Sayre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Entellus Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Dysfu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Complication Rate	Number of subjects who experience serious device- or procedure-related adverse events	Through 6 months post-procedure
Secondary	Technical Success Rate	Percent of successful ET dilations per attempted ET dilations	Immediately after procedure
Secondary	Revision Rate	Percent of participants undergoing repeat balloon dilation procedure on an ET that was initially treated with an XprESS device	12 months
Secondary	Mean Change in Overall ETDQ-7 Score	Mean change from baseline to 12 months in the overall ETDQ-7 score. 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.	12 months postdilation
Secondary	Mean Change in Overall ETDQ-7 Score	Mean change from baseline to 6 months in the overall ETDQ-7 score. 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 months postdilation
Secondary	Mean Change in Overall ETDQ-7 Score	Mean change from baseline to 3 months in the overall ETDQ-7 score. 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.	3 months postdilation
Secondary	Mean Change in Overall ETDQ-7 Score	Mean change from baseline to 6 weeks in the overall ETDQ-7 score. 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 postdilation