Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia

NCT ID: NCT02228720

Last Updated: 2017-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-01-31

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.

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.

Conditions

Chronic Sinusitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Propel Nova Sinus Implant

Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days

Group Type: EXPERIMENTAL

Propel Nova Sinus Implant

Intervention Type: DEVICE

Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days

Interventions

Propel Nova Sinus Implant

Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days

Intervention Type: DEVICE

Other Intervention Names

Propel Contour Sinus Implant (mometasone furoate, 370 mcg)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intersect ENT

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William J. Brown, MD

Role: PRINCIPAL_INVESTIGATOR

South Florida ENT Associates, PA

Locations

South Florida ENT Associates

Miami, Florida, United States

Ohio Sinus Institute

Dublin, Ohio, United States

Countries

United States

Other Identifiers

P500-0414

Identifier Type: -

Identifier Source: org_study_id