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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Sinusitis
• Intervention / Treatment: Device: Propel Nova Sinus Implant

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33176
      • South Florida ENT Associates
  • Ohio
    • Dublin, Ohio, United States, 43016
      • Ohio Sinus Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propel Nova Sinus Implant; Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days	Device: Propel Nova Sinus Implant; Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days; Other Names: Propel Contour Sinus Implant (mometasone furoate, 370 mcg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Placement Success Rate	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.	Baseline Procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ostial Patency	Ostial patency grading scale from 0 (patent) to 1 (Occluded/Restenosed)	Baseline, Day 30, Day 90
Adhesion/Scarring Grade 2 & 3	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)	Baseline, Day 30, Day 90
Degree of Inflammation	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)	Baseline, Day 30, Day 90
Sino-Nasal Outcome Test (SNOT) 22	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	Baseline, Day 30, Day 90

Collaborators and Investigators

• Sponsor: Intersect ENT
• Investigators: Principal Investigator: William J. Brown, MD, South Florida ENT Associates, PA

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: June 25, 2014
• First Submitted That Met QC Criteria: August 27, 2014
• First Posted (Estimate): August 29, 2014

Study Record Updates

• Last Update Posted (Actual): August 4, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Chronic Sinusitis; Endoscopic Sinus Surgery
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents; Mometasone Furoate
• Other Study ID Numbers: P500-0414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No