Phase
Condition
Acute Rhinitis
Nasal Obstruction
Bronchiectasis
Treatment
Novapak Nasal Sinus Packing and Stent
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is at least 18 years of age.
Subject undergoing nasal/sinus surgery with the intended need for nasal sinuspacking (i.e., Novapak).
After being informed of the nature of the study; the subject understands, agrees toits provisions, is willing to participate and provide written consent.
Mentally stable and able to follow the instructions forself-assessment/questionnaire completion.
Exclusion
Exclusion Criteria:
Subject has a shellfish allergy.
Subject has known bleeding disorder or prescribed anticoagulants.
Subject has craniofacial abnormalities that may interfere with access to thesinuses.
Subject is immunocompromised (e.g., taking immunosuppressive medication).
Subject is participating in another investigational device, biologic, or drug studyand has not completed the primary endpoint(s) or if there is a potential forclinical interference beyond the primary endpoint.
Study Design
Study Description
Connect with a study center
St. Joseph's Health Care
London, Onterio N6A 4V2
CanadaSite Not Available
ENT Associates of South Florida
Boca Raton, Florida 33487
United StatesSite Not Available
University of Miami
Miami, Florida 33136
United StatesSite Not Available
University of South Florida
Tampa, Florida 33612
United StatesSite Not Available
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