A prospective, multi-center, randomized, controlled, single-blinded 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 个研究点目标入组 100 人开始时间: 2008年6月23日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Diagnosis of CRS defined as:
•- Symptoms present for >12 weeks
•- 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 rpesence 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). Images should be acquired or reformatted into coronal section, with a maximum thickness of 3 mm. Follow-up CT should be performed using a similar protocol to the original scan
•2. Average Score of 40-80 mm on the Patient Subjective Symptom Score (PSSS)
•3. 18 – 85 years of age
•4. Adequate access for application of approximately 1.5mL of material on to Ostiomeatal Complex (OMC)
•5. Willing and able to return for all required follow-up study visits.
•6. Signed an informed consent form
•7. Females of childbearing potential are not pregnant or lactating and agree not to become pregnant for the duration of the study
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•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 muccocele
•11. Nasal intubation within 4 weeks of study run-in period (Day -7)
•12. Wegener’s granulomatosis or sarcoidosis
•13. Suspicion of sinonasal neoplasm
•14. Use of nasal irrigation during study duration
•15. Use of systemic corticosteroids within 4 weeks of study run-in period (Day -7)
•16. Pregnant or planning to get pregnant
•17. Current use of orally inhaled corticosteroids
•18. Active sinus infection as evidence by frank purulence/pus
•19. Current use of systemic antibiotics
•20. PRN use of nasal corticosteroids, oral and/or nasal decongestants/antihistamines, leukotriene inhibitors, and/or mastcell stabilizers (i.e.,all medications must be stable dosing for 14 days prior to study run-in period (Day -7)).

发起方

Carbylan BioSurgery, Inc.