Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia

NCT02228720 | Completed Results FDA Device

• 1 other identifier: P500-0414
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Sinusitis

Keywords

Chronic Sinusitis; Endoscopic Sinus Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Ostial Patency

  Baseline, Day 30, Day 90

• Adhesion/Scarring Grade 2 & 3

  Baseline, Day 30, Day 90

• Degree of Inflammation

  Baseline, Day 30, Day 90

• Sino-Nasal Outcome Test (SNOT) 22

  Baseline, Day 30, Day 90

Study Arms (1)

Propel Nova Sinus Implant

EXPERIMENTAL

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

Device: Propel Nova Sinus Implant

Interventions

Propel Nova Sinus Implant DEVICE

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

Also known as: Propel Contour Sinus Implant (mometasone furoate, 370 mcg)

Propel Nova Sinus Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intersect ENT: lead

Study Sites (2)

South Florida ENT Associates

Miami, Florida, 33176, United States

Location

Ohio Sinus Institute

Dublin, Ohio, 43016, United States

Location

Results Point of Contact

• Title: James Stambaugh
• Organization: Intersect ENT

jstambaugh@intersectent.com

6506412103

Study Officials

• William J. Brown, MD

  South Florida ENT Associates, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Propel Nova Sinus Implant

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: August 29, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2015
• Last Updated: August 4, 2017
• Results First Posted: August 4, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)