Status:
COMPLETED
Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up
Lead Sponsor:
Entellus Medical, Inc.
Conditions:
Chronic Sinusitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to show that long-term symptom improvement after sinus balloon dilation is not worse than symptom improvement after functional endoscopic sinus surgery (FESS) and that f...
Detailed Description
This is a postmarket, multicenter, prospective, randomized clinical trial conducted at up to 15 US clinical sites comparing the efficacy of balloon sinus dilation with traditional endoscopic sinus sur...
Eligibility Criteria
Inclusion
- 18 years or older
- maxillary sinus disease
- chronic sinusitis
Exclusion
- fungal disease
- Samter's triad
- hemophilia
- prior sinus surgery
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT01525849
Start Date
December 1 2011
End Date
May 1 2014
Last Update
February 24 2017
Active Locations (1)
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1
Entellus Medical
Plymouth, Minnesota, United States, 55447