XprESS Eustachian Tube Dilation Study
- Conditions
- Eustachian Tube Dysfunction
- Interventions
- Device: XprESSOther: Control
- Registration Number
- NCT02391584
- Lead Sponsor
- Entellus Medical, Inc.
- Brief Summary
Study to assess the safety and efficacy of the XprESS device for transnasal Eustachian tube dilation.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- ≥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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description XprESS XprESS Balloon dilation of the Eustachian tube Control Control Continued medical management
- Primary Outcome Measures
Name Time Method Change From Baseline in Mean Overall ETDQ-7 Scores 6 weeks post procedure (treatment arm) or randomization (control arm) 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.Complication Rate Through 6 months post-procedure Number of subjects who experience serious device- or procedure-related adverse events
- Secondary Outcome Measures
Name Time Method Revision Rate 12 months Percent of participants undergoing repeat balloon dilation procedure on an ET that was initially treated with an XprESS device
Technical Success Rate Immediately after procedure Percent of successful ET dilations per attempted ET dilations
Mean Change in Overall ETDQ-7 Score 6 weeks postdilation 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.
Trial Locations
- Locations (5)
Colorado Sinus Institute
🇺🇸Denver, Colorado, United States
Donald Guthrie Foundation
🇺🇸Sayre, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Ear Nose Throat and Sinus Clinic
🇺🇸North Platte, Nebraska, United States
Austin Ear Clinic
🇺🇸Austin, Texas, United States