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

• ClinicalTrials.gov Identifier: NCT02228720
• Recruitment Status: Completed
• First Posted: August 29, 2014
• Results First Posted: August 4, 2017
• Last Update Posted: August 4, 2017
• Sponsor: Intersect ENT
• Information provided by (Responsible Party): Intersect ENT

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Chronic Sinusitis	Device: Propel Nova Sinus Implant	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Propel Nova Sinus Implant
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: The EXCEED Study: A Clinical Evaluation of the Drug-Eluting Propel Nova Sinus Implant When Placed in Peripheral Sinus Ostia to Maintain Patency
• Study Start Date: June 2014
• Actual Primary Completion Date: October 2014
• Actual Study Completion Date: January 2015

Arms and Interventions

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 Name: Propel Contour Sinus Implant (mometasone furoate, 370 mcg)

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Ostial Patency [ Time Frame: Baseline, Day 30, Day 90 ]
   Ostial patency grading scale from 0 (patent) to 1 (Occluded/Restenosed)
2. 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)
3. 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)
4. 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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, Florida

South Florida ENT Associates

Miami, Florida, United States, 33176

United States, Ohio

Ohio Sinus Institute

Dublin, Ohio, United States, 43016

Sponsors and Collaborators

Intersect ENT

Investigators

• Principal Investigator: William J. Brown, MD; South Florida ENT Associates, PA

More Information

• Responsible Party: Intersect ENT
• ClinicalTrials.gov Identifier: NCT02228720
• Other Study ID Numbers: P500-0414
• First Posted: August 29, 2014
• Results First Posted: August 4, 2017
• Last Update Posted: August 4, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Intersect ENT:

Chronic Sinusitis; Endoscopic Sinus Surgery

Additional relevant MeSH terms:

Sinusitis; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Mometasone Furoate; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents