N/A
Completed N=60
XprESS Eustachian Tube Dilation Study
Source: ClinicalTrials.gov NCT02391584 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Change From Baseline in Mean Overall ETDQ-7 Scores — -2.9; -0.6 units on a scale — p=<0.0001
Summary
Study to assess the safety and efficacy of the XprESS device for transnasal Eustachian tube dilation.
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 |
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. Informational only — not medical advice.