Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia (EXCEED)

Intersect ENT

Status

Completed

Conditions

Chronic Sinusitis

Treatments

Device: Propel Nova Sinus Implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT02228720

P500-0414

Details and patient eligibility

About

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.

Full description

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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.