Status:
COMPLETED
XprESS ET Registry
Lead Sponsor:
Entellus Medical, Inc.
Collaborating Sponsors:
North American Science Associates Ltd.
Conditions:
Eustachian Tube Dysfunction
Eligibility:
All Genders
18+ years
Brief Summary
A prospective, multicenter, registry of patients undergoing balloon dilation of the Eustachian tubes (ET).
Detailed Description
This is a prospective, multicenter, single-arm, postmarket registry enrolling up to 300 participants who are planning to undergo balloon dilation of the Eustachian tubes for treatment of chronic/persi...
Eligibility Criteria
Inclusion
- Be at least 18 years old
- Have been diagnosed with persistent/chronic Eustachian tube dysfunction (duration 3 months or more)
- Be a candidate for unilateral or bilateral Eustachian tube balloon dilation using the XprESS device
- Be able to read and understand English
- Be willing and able to provide informed consent
- Be willing to comply with the protocol requirements
Exclusion
- Have a history of patulous Eustachian tube
- Require additional ear surgery (eg, myringotomy, tympanostomy) at the time of study procedure
- Have evidence of internal carotid artery dehiscence
- Be currently participating in any other drug or device clinical studies, excluding postapproval or marketing registry studies
Key Trial Info
Start Date :
June 5 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 28 2020
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT04136977
Start Date
June 5 2018
End Date
August 28 2020
Last Update
September 30 2020
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Breathe Clear Institute
Torrance, California, United States, 90503
2
Colorado ENT and Allergy
Colorado Springs, Colorado, United States, 80909
3
Augusta ENT and Allergy
Evans, Georgia, United States, 30809
4
St. Vincent Anderson Hospital
Anderson, Indiana, United States, 46016