N/A
N=74
Healthcare Utilization and Outcomes of FinESS Treatment in the Office
Rhinosinusitis
Bottom Line
View on ClinicalTrials.gov: NCT00986830 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Sino-Nasal Outcomes Test — 2.3; 1.1 score on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FinESS Sinus Treatment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Entellus Medical, Inc.
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sino-Nasal Outcomes Test |
2.3; 1.1 | <0.0001 sig |
| SECONDARY Rhinosinusitis Symptom Inventory (RSI) Nasal Symptoms Domain |
53.7; 20.7 | <0.0001 sig |
| SECONDARY Rhinosinusitis Symptom Inventory (RSI) Facial Symptoms Domain |
61.4; 24.4 | <0.0001 sig |
| SECONDARY Rhinosinusitis Symptom Inventory (RSI) Oropharyngeal Symptoms Domain |
40.6; 15.4 | <0.0001 sig |
| SECONDARY Rhinosinusitis Symptom Inventory (RSI) Systemic Symptoms Domain |
40.6; 15.4 | <0.0001 sig |
| SECONDARY Number of Participants Using Nasal Steroids |
47; 36 | 0.009 sig |
| SECONDARY Number of Participants Using Antihistamines |
33; 28 | 0.292 |
| SECONDARY Number of Participants Using Antibiotics |
5.5; 2.3 | <0.0001 sig |
| SECONDARY Number of Participants With Device and/or Procedure-related Adverse Events |
16 | — |
Summary
A prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office.
Eligibility Criteria
Inclusion Criteria
- 18 years or older
- Male or female subjects
- Diagnosis of rhinosinusitis (CT radiographic evidence and medical evaluation)
- Willing to comply with protocol requirements
- Able to provide consent
Exclusion Criteria
- Hemophilia
- Cystic fibrosis
- Ciliary dysfunction
- Severe septal deviation causing obstruction of the ostiomeatal unit
- Pregnant females
Data sourced from ClinicalTrials.gov (NCT00986830). 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.