Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia

Overview

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 Title of Study: “The EXCEED Study: A Clinical Evaluation of the Drug-Eluting Propel Nova Sinus Implant When Placed in Peripheral Sinus Ostia to Maintain Patency”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Device Feasibility
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2014

Detailed 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.

Interventions

  • Device: Propel Nova Sinus Implant
    • Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days

Arms, Groups and Cohorts

  • Experimental: Propel Nova Sinus Implant
    • Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days

Clinical Trial Outcome Measures

Primary Measures

  • Device Placement Success Rate
    • Time Frame: Baseline Procedure
    • Defined as successful access to and placement of the Propel Nova Sinus Implant in the frontal or maxillary sinus ostium within two attempts. Calculated as a proportion where the numerator is the number of successful device placements and the denominator is the number of attempted sinuses.

Secondary Measures

  • Ostial Patency
    • Time Frame: Baseline, Day 30, Day 90
    • Ostial patency grading scale from 0 (patent) to 1 (Occluded/Restenosed)
  • Adhesion/Scarring Grade 2 & 3
    • Time Frame: Baseline, Day 30, Day 90
    • Adhesion/scarring grading scale from 0 (No visible granulation/scarring), 1 (Minimal amount of scarring/contraction observed but non-obstructing the frontal or maxillary sinus ostium), 2 (moderate amount of obstructive scar tissue/contraction present in the frontal or maxillary sinus ostium), 3 (Significant scar tissue/ contraction causing obstruction of the frontal or maxillary sinus ostium)
  • Degree of Inflammation
    • Time Frame: Baseline, Day 30, Day 90
    • Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes)
  • Sino-Nasal Outcome Test (SNOT) 22
    • Time Frame: Baseline, Day 30, Day 90
    • Validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a scale of 0 (no problem) to 5 (problem as bad as it can be), resulting in a maximum total score of 110

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Intersect ENT
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • William J. Brown, MD, Principal Investigator, South Florida ENT Associates, PA

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