clinical evaluation of propel nova sinus implant in peripheral sinus ostia

Conditions: Chronic Sinusitis

Summary: this is a feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting propel nova sinus implant when used in chronic sinusitis patients undergoing sinus surgery of peripheral sinus ostia.

this is a prospective, single-center, single-arm, open label feasibility study aiming to enroll at least 10 patients and a maximum of 15 patients to achieve 30 treated sinuses. the objective of this feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting propel nova sinus implant when used in chronic sinusitis (cs) patients undergoing sinus surgery of peripheral sinus ostia.

Eligibility criteria:
inclusion criteria: * patient is ≥ 18 years of age. * patient is willing and able to comply with protocol requirements. * patient has cs as confirmed by ct scan and defined as symptoms lasting longer than 8 consecutive weeks in duration with inflammation of the mucosa of the nose and paranasal sinuses. * patient's condition and the planned intervention will involve at least two and a maximum of four peripheral sinuses (frontal or maxillary sinuses or combination of both). * patient is a candidate for a planned intervention involving sinus surgery in the operating room or office setting. * patient has nasal polyps no greater than grade 2. * patient with nasal polyps greater than 2 are eligible after their reduction/removal during ess without significant complications that would confound the study results and leaving the patient's anatomy amenable to sinus implant placement, as judged by the operating physician. * female patients of child-bearing potential must not be pregnant and must agree to not become pregnant during the course of the study. * female patients of child-bearing potential must agree to use consistent and acceptable method/s of birth control during the course of the study. * cs diagnosis confirmed and documented by ct scan within 6 months of the procedure. * patient has a minimum total ct stage (lund-mackay method) of 6. * patient has disease in frontal and/or maxillary sinuses confirmed by ct scan. * planned ess includes bilateral ethmoidectomy (if judged necessary), frontal sinus surgery using draf ii (a or b) dissection and/or balloon dilation, with minimum of 5-mm diameter opening created. in the case of maxillary sinus surgery, traditional antrostomy or balloon dilation, with or without removal of uncinate process, should be performed with minimum of 5-mm diameter opening created. * technique used for frontal or maxillary sinus surgery was the same on both sides (e.g. surgical dissection alone bilaterally, balloon dilation alone bilaterally, or both bilaterally) * septoplasty for access to the ostio-meatal complex is permitted. exclusion criteria: * patient has presence of grade 3 or 4 polyposis, unless removed during surgery and preceding implant placement. * patient has presence of adhesions/scarring grades 3 or 4, unless removed during surgery and preceding implant placement. * patient has known history of immune deficiency (e.g., igg subclass deficiency or iga deficiency, hiv). * patient has concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease (e.g., cancer, hiv, etc.). * patient has oral-steroid dependent condition such as copd, asthma or other condition. * patient has known history of allergy or intolerance to corticosteroids or mometasone furoate. * patient has clinical evidence of acute bacterial sinusitis (e.g. acute increase in purulent discharge, fever, facial pain etc.). * patient has clinical evidence or suspicion of invasive fungal sinusitis (e.g. bone erosion on prior ct scan, necrotic sinus tissue, etc.). * patient has evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90-day period. * patient is currently participating in another clinical trial. * patient has history of insulin dependent diabetes mellitus. * patient has previously undergone ess and experienced a csf leak or has residual compromised vision as a result of a complication in a prior ess procedure. * patient has known dehiscence of the lamina papyracea. * patient has evidence of active viral illness (e.g., tuberculosis, ocular herpes simplex, chickenpox or measles). * significant complication during the current peripheral ostia surgery/such as excessive blood loss, csf leak or punctured lamina papyracea. * current surgical intervention (operating room or office setting) is aborted for any reason.

Keywords: chronic sinusitis endoscopic sinus surgery