Status:
UNKNOWN
Gel-Sinuplasty for Chronic Rhinosinusitis With and Without Nasal Polyposis
Lead Sponsor:
LifeBridge Health
Conditions:
Chronic Sinusitis, Ethmoidal
Chronic Sinusitis - Ethmoidal Anterior
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To assess the efficacy of intra-sinus installation of a poloxamer gel that releases antibiotics and corticosteroids topically after balloon sinuplasty in chronic sinusitis patients with or without pol...
Detailed Description
STUDY DESIGN This is a single-blinded Randomized Control Trial study, in which every patient receives active gel on one side and placebo on the other (L or R to be randomly selected). Sixty patients w...
Eligibility Criteria
Inclusion
- Chronic sinusitis symptoms with or without polyps
- Trial of at least 2 courses of oral antimicrobial treatment without significant improvement
- CAT scan showing evidence of bilateral symmetric chronic sinusitis with or without polypss
- Endoscopic confirmation of CRS
Exclusion
- Minor (Less than \<18 years of age).
- Pregnant and breastfeeding women.
- Allergy to specific antibiotics
- Patient currently taking oral corticosteroids.
- Patient currently taking oral antibiotics.
Key Trial Info
Start Date :
July 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 7 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03472144
Start Date
July 7 2017
End Date
December 7 2019
Last Update
March 21 2018
Active Locations (1)
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1
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215