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Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus (PROGRESS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02266810
First Posted: October 17, 2014
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Advance Research Associates
Information provided by (Responsible Party):
Intersect ENT
  Purpose
The objective of the PROGRESS Study is to assess the safety and efficacy of the Propel Mini and Propel Nova steroid-eluting Sinus Implants when placed in the frontal sinus opening following frontal sinus surgery in patients with chronic sinusitis.

Condition Intervention Phase
Chronic Sinusitis Device: PROPEL Mini Sinus Implant. Procedure: Sinus Surgery alone Device: Propel Nova Sinus Implant Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The PROGRESS Study: Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implants Following Surgical Opening of the Frontal Sinus for Chronic Sinusitis: A Randomized Blinded Controlled Study

Resource links provided by NLM:


Further study details as provided by Intersect ENT:

Primary Outcome Measures:
  • Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort) [ Time Frame: Day 30 ]

    The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews.

    Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).


  • Percent of Sinuses That Require Post-operative Interventions (Propel Nova Cohort) [ Time Frame: Day 30 ]

    The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews.

    Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).



Secondary Outcome Measures:
  • Need for Post-operative Interventions (Propel Mini Cohort) [ Time Frame: Day 30 ]

    Need for post-operative interventions by clinical investigators at Day 30

    Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).


  • Need for Surgical Interventions (Propel Mini Cohort) [ Time Frame: Day 30 ]

    Need for Surgical Interventions by clinical investigators at Day 30.

    Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3.

    Adhesions/Scarring was assessed based on a 4-point scale as follows:

    0= No visible granulation/scarring in the FSO

    1. Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted)
    2. Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted)
    3. Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)

  • Inflammation (Propel Mini Cohort) [ Time Frame: Day 30 ]
    The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis.

  • Occlusion/Restenosis (Propel Mini Cohort) [ Time Frame: Day 30 ]

    Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows:

    0=Patent

    1. Restenosed/Partially Occluded
    2. Occluded

  • Need for Post-operative Interventions (Propel Nova Cohort) [ Time Frame: Day 30 ]

    Need for post-operative interventions by clinical investigators at Day 30.

    Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale by investigators), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).


  • Need for Surgical Interventions (Propel Nova Cohort) [ Time Frame: Day 30 ]

    Need for Surgical Interventions by clinical investigators at Day 30

    Need for Surgical Interventions by clinical investigators at Day 30.

    Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3.

    Adhesions/Scarring was assessed based on a 4-point scale as follows:

    0= No visible granulation/scarring in the FSO

    1. Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted)
    2. Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted)
    3. Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)

  • Inflammation (Propel Nova Cohort) [ Time Frame: Day 30 ]
    The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis.

  • Occlusion/Restenosis (Propel Nova Cohort) [ Time Frame: Day 30 ]

    Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows:

    0=Patent

    1. Restenosed/Partially Occluded
    2. Occluded


Enrollment: 160
Study Start Date: September 2014
Study Completion Date: October 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PROPEL Mini Sinus Implant
Propel Mini placed in frontal sinus opening following ESS
Device: PROPEL Mini Sinus Implant.
Placement of sinus implant following frontal sinus surgery
Active Comparator: Sinus Surgery alone: cohort 1
Sinus Surgery only: cohort 1: ESS with standard post-operative care.
Procedure: Sinus Surgery alone
Sinus surgery only, without implant placement
Experimental: PROPEL Nova Sinus Implant
Propel Nova placed in frontal sinus opening following ESS
Device: Propel Nova Sinus Implant
Placement of sinus implant following frontal sinus surgery
Other Name: PROPEL contour Sinus Implant
Active Comparator: Sinus Surgery alone: cohort 2
Sinus Surgery only: cohort 2: ESS with standard post-operative care.
Procedure: Sinus Surgery alone
Sinus surgery only, without implant placement

Detailed Description:
This is a prospective, randomized, blinded, controlled, multicenter study enrolling two consecutive cohorts of up to 80 patients each (Propel Mini cohort followed by Propel Nova cohort). The study patients will undergo implant placement on one side following ESS that includes bilateral frontal sinus surgery by traditional surgical technique or balloon dilation.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Patient has CRS confirmed by CT scan and defined as symptoms lasting longer than 12 consecutive weeks in duration with inflammation of the mucosa of the nose and paranasal sinuses.
  • Patient has a clinical indication for and has consented to ESS including bilateral frontal sinus surgery.
  • Chronic sinusitis diagnosis confirmed and documented by CT scan within 6 months of the procedure.
  • Patient has bilateral disease in both frontal sinuses confirmed by Lund-Mackay score of ≥1 on each side.
  • Planned sinus surgery includes bilateral ethmoidectomy (if judged necessary) and frontal sinus enlargement using Draf II (A or B) dissection or balloon dilation, with minimum of 5-mm diameter opening created.
  • Technique used for frontal sinus surgery is 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.
  • ESS including bilateral frontal sinus surgery has been successfully completed without significant complication that, in the opinion of the investigator, would confound study results, and the patient's anatomy remains amenable to implant placement.

Exclusion Criteria:

  • Known history of immune deficiency such as immunoglobin G or A subclass deficiency, or Human Immunodeficiency Virus (HIV)
  • Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or asthma or other condition
  • Known history of allergy or intolerance to corticosteroids or mometasone furoate
  • Clinical evidence of acute bacterial sinusitis
  • Clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on CT scan, necrotic sinus tissue)
  • Active viral illness
  • Concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease
  • Clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90 day follow-up period
  • Currently participating in another clinical trial
  • History of insulin dependent diabetes mellitus
  • Patient has previously undergone ESS and experienced a CSF leak or has compromised vision as a result of a complication in a prior ESS procedure
  • Significant complication during the current frontal sinus surgery procedure such as excessive blood loss, CSF leak or punctured lamina papyracea
  • Current ESS including frontal sinus surgery is aborted for any reason.
  • At least one side is not amenable for implant placement.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02266810


Locations
United States, California
Sacramento Ear, Nose and Throat
Sacramento, California, United States, 95815
Breathe Clear Institute of Sinus and Allergy Relief
Torrance, California, United States, 90503
United States, Connecticut
The Connecticut Center for Advanced ENT Care
Norwalk, Connecticut, United States, 06851
United States, District of Columbia
George Washington University Medical Faculty Associates
Washington, D.C., District of Columbia, United States, 20006
United States, Georgia
ENT of Georgia
Atlanta, Georgia, United States, 30342
United States, Kentucky
Advanced ENT and Allergy
Louisville, Kentucky, United States, 40207
United States, New York
Albany ENT and Allergy
Albany, New York, United States, 12206
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Texas
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
United States, Virginia
East Virginia Medical School
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Intersect ENT
Advance Research Associates
Investigators
Principal Investigator: Timothy L. Smith, MD, MPH Oregon Health and Science University
Principal Investigator: Amber U. Luong, MD, PhD The University of Texas Health Science Center, Houston
  More Information

Publications:
Responsible Party: Intersect ENT
ClinicalTrials.gov Identifier: NCT02266810     History of Changes
Other Study ID Numbers: P500-0514
First Submitted: September 15, 2014
First Posted: October 17, 2014
Results First Submitted: June 10, 2016
Results First Posted: October 6, 2017
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents