N/A
N=151
Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up
Chronic Sinusitis
Bottom Line
View on ClinicalTrials.gov: NCT01525849 ↗Enrolled (actual)
151
Serious AEs
2.0%
Results posted
Feb 2017
Primary outcome: Primary: Sinus Symptom Improvement — -1.59; -1.60; 0.88; 0.88 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Balloon Sinus Dilation (Device); Functional Endoscopic Sinus Surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Entellus Medical, Inc.
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sinus Symptom Improvement |
-1.59; -1.60; 0.88; 0.88 | <0.001 sig |
| PRIMARY Debridements |
0.23; 1.03 | <0.0001 sig |
| SECONDARY Revision Rate |
1; 1 | 0.628 |
| SECONDARY Complication Rate |
0; 0 | — |
| SECONDARY Recovery Time |
1.7; 5.0 | <0.0001 sig |
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 fewer postoperative debridements are required after balloon dilation than after FESS.
Eligibility Criteria
Inclusion Criteria
- 18 years or older
- maxillary sinus disease
- chronic sinusitis
Exclusion Criteria
- fungal disease
- Samter's triad
- hemophilia
- prior sinus surgery
Data sourced from ClinicalTrials.gov (NCT01525849). 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.