N/A
N=60
XprESS Eustachian Tube Dilation Study
Eustachian Tube Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT02391584 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Change From Baseline in Mean Overall ETDQ-7 Scores — -2.9; -0.6 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- XprESS (Device); Control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Entellus Medical, Inc.
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Overall ETDQ-7 Scores |
-2.9; -0.6 | <0.0001 sig |
| PRIMARY Complication Rate |
0; 0 | — |
| SECONDARY Technical Success Rate |
100 | — |
| SECONDARY Revision Rate |
— | — |
| SECONDARY Mean Change in Overall ETDQ-7 Score |
-2.5 | <0.0001 sig |
| SECONDARY Mean Change in Overall ETDQ-7 Score |
-2.5 | <0.0001 sig |
| SECONDARY Mean Change in Overall ETDQ-7 Score |
-2.5 | <0.0001 sig |
| SECONDARY Mean Change in Overall ETDQ-7 Score |
-2.5 | <0.0001 sig |
Summary
Study to assess the safety and efficacy of the XprESS device for transnasal Eustachian tube dilation.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02391584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.