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

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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:
Information provided by (Responsible Party):
Intersect ENT

Tracking Information
First Submitted Date  ICMJE June 25, 2014
First Posted Date  ICMJE August 29, 2014
Results First Submitted Date  ICMJE August 23, 2016
Results First Posted Date  ICMJE August 4, 2017
Last Update Posted Date August 4, 2017
Study Start Date  ICMJE June 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2017)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2017)
  • Ostial Patency [ Time Frame: Baseline, Day 30, Day 90 ]
    Ostial patency grading scale from 0 (patent) to 1 (Occluded/Restenosed)
  • 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)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia
Official Title  ICMJE The EXCEED Study: A Clinical Evaluation of the Drug-Eluting Propel Nova Sinus Implant When Placed in Peripheral Sinus Ostia to Maintain Patency
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Propel Nova Sinus Implant
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Chronic Sinusitis
Intervention  ICMJE 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)
Study Arms  ICMJE Experimental: Propel Nova Sinus Implant
Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days
Intervention: Device: Propel Nova Sinus Implant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2017)
15
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02228720
Other Study ID Numbers  ICMJE P500-0414
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Intersect ENT
Study Sponsor  ICMJE Intersect ENT
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William J. Brown, MD South Florida ENT Associates, PA
PRS Account Intersect ENT
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP