NL-OMON32392
Completed
Phase 2
A prospective study to evaluate the safety and efficacy of AdvaCoat Mx sinus gel for treatment of chronic rhinosinusitis without nasal polyps. - AdvaCoat Mx sinus gel study for chronic rhinosinusitis without nasal polyps
Carbylan BioSurgery, Inc.0 sites49 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Chronic rhinosinusitis
- Sponsor
- Carbylan BioSurgery, Inc.
- Enrollment
- 49
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Diagnosis of CRS defined as:
- •\- Symptoms present for \>12 consecutive weeks
- •\- At least two of the following:
- •\* Anterior and/or posterior mucoid drainage
- •\* Nasal congestion
- •\* Facial pain / pressure / fullness
- •\- Both of the following:
- •\* Nasal endoscopic examination confirming inflammation and/or edema of the ostiomeatal complex without the presence of polyps and/or previous sinus surgical procedures
- •\* Evidence of CRS on CT (minimum score of 4 with at least two points coming from the sinuses; reference Table 1 for grading scale);2\. Average score of 40\-80 mm on the Patient Subjective Symptom Score (PSSS) at the end of the run\-in period
- •3\. 18 \- 85 years of age
Exclusion Criteria
- •1\. Unilateral sinus disease
- •2\. Evidence of polyps within or beyond the middle meatus by nasal endoscopy
- •3\. Samter\*s Triad
- •4\. Previous or planned nasal or sinus surgery, including sinuplasty
- •5\. Steroid dependent asthma
- •6\. A known sensitivity to hyaluronan products, corticosteroids or any excipients contained within the formulation of Kenacort A\-10
- •7\. Cystic fibrosis or any immune deficiency that may interfere with wound healing
- •8\. Any disease or condition that interferes with safe completion of initial or follow\-up assessments
- •9\. Anatomical abnormalities within middle meatus by endoscopy
- •10\. Current evidence of sinus mucocele
Outcomes
Primary Outcomes
Not specified
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