Phase 3
Completed N=105
A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis
Chronic Sinusitis
Source: ClinicalTrials.gov NCT01253577 ↗
Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcomePrimary: Percentage of Sinuses Requiring Post-operative Intervention — 33.3; 46.9 percentage of sinuses — p=0.0280
Summary
The purpose of this study is to assess the safety and efficacy of the Propel mometasone furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Sinusitis (CS).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Sinuses Requiring Post-operative Intervention |
33.3; 46.9 | 0.0280 sig |
| PRIMARY Percentage of Patients With Clinically Significant Increase in Intra-ocular Pressure |
— | <0.0001 sig |
| SECONDARY Percentage of Sinuses That Developed Frank Polyposis |
18.8; 34.1 | 0.0023 sig |
Eligibility Criteria
Inclusion Criteria
- Patient has bilateral chronic sinusitis confirmed by CT scan and defined as inflammation of the mucosa of the nose and paranasal sinuses of at least 8 consecutive weeks' duration.
- Patient is indicated for and has consented to FESS.
- FESS successfully completed without significant complication that in the opinion of the physician would confound study results and the patient's anatomy remains amenable to Sinus Stent placement.
CT Imaging Inclusion Criteria:
- CS diagnosis confirmed and documented by CT Scan within 6 months of the procedure.
- Patient has minimum total CT score (Lund-Mackay method) of 6. • Patient has bilateral ethmoid sinus disease confirmed by CT.
Exclusion Criteria
- insulin dependent diabetics
- oral steroid dependent condition
- glaucoma, ocular hypertension, posterior subcapsular cataracts
- middle turbinate resection
Data sourced from ClinicalTrials.gov (NCT01253577). 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. Informational only — not medical advice.