Clinical trial NCT02228720: Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Sinusitis
Keywords: Chronic Sinusitis
Endoscopic Sinus Surgery
Lead sponsor: Intersect ENT
Sponsor class: INDUSTRY
First posted: 2014-08-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Propel Nova Sinus Implant
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Primary outcomes:
measure: Device Placement Success Rate
timeFrame: Baseline Procedure
Secondary outcomes:
measure: Ostial Patency
timeFrame: Baseline, Day 30, Day 90
measure: Adhesion/Scarring Grade 2 & 3
timeFrame: Baseline, Day 30, Day 90
measure: Degree of Inflammation
timeFrame: Baseline, Day 30, Day 90
measure: Sino-Nasal Outcome Test (SNOT) 22
timeFrame: Baseline, Day 30, Day 90
Other outcomes:
Locations:
city: Miami
country: United States
facility: South Florida ENT Associates
state: Florida
city: Dublin
country: United States
facility: Ohio Sinus Institute
state: Ohio
Study officials:
affiliation: South Florida ENT Associates, PA
name: William J. Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: