search
Back to results

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

Primary Purpose

Chronic Sinusitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PROPEL Mini Sinus Implant.
Sinus Surgery alone
Propel Nova Sinus Implant
Sponsored by
Intersect ENT
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinusitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sacramento Ear, Nose and Throat
  • Breathe Clear Institute of Sinus and Allergy Relief
  • The Connecticut Center for Advanced ENT Care
  • George Washington University Medical Faculty Associates
  • ENT of Georgia
  • Advanced ENT and Allergy
  • Albany ENT and Allergy
  • Oregon Health and Science University
  • University of Texas Health Science Center at Houston
  • East Virginia Medical School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

PROPEL Mini Sinus Implant

Sinus Surgery alone: cohort 1

PROPEL Nova Sinus Implant

Sinus Surgery alone: cohort 2

Arm Description

Propel Mini placed in frontal sinus opening following ESS

Sinus Surgery only: cohort 1: ESS with standard post-operative care.

Propel Nova placed in frontal sinus opening following ESS

Sinus Surgery only: cohort 2: ESS with standard post-operative care.

Outcomes

Primary Outcome Measures

Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort)
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)
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)
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)
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 Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted) Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted) Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)
Inflammation (Propel Mini Cohort)
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)
Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows: 0=Patent Restenosed/Partially Occluded Occluded
Need for Post-operative Interventions (Propel Nova Cohort)
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)
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 Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted) Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted) Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)
Inflammation (Propel Nova Cohort)
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)
Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows: 0=Patent Restenosed/Partially Occluded Occluded

Full Information

First Posted
September 15, 2014
Last Updated
July 17, 2018
Sponsor
Intersect ENT
Collaborators
Advance Research Associates
search

1. Study Identification

Unique Protocol Identification Number
NCT02266810
Brief Title
Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus
Acronym
PROGRESS
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intersect ENT
Collaborators
Advance Research Associates

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Intra-patient control
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PROPEL Mini Sinus Implant
Arm Type
Experimental
Arm Description
Propel Mini placed in frontal sinus opening following ESS
Arm Title
Sinus Surgery alone: cohort 1
Arm Type
Active Comparator
Arm Description
Sinus Surgery only: cohort 1: ESS with standard post-operative care.
Arm Title
PROPEL Nova Sinus Implant
Arm Type
Experimental
Arm Description
Propel Nova placed in frontal sinus opening following ESS
Arm Title
Sinus Surgery alone: cohort 2
Arm Type
Active Comparator
Arm Description
Sinus Surgery only: cohort 2: ESS with standard post-operative care.
Intervention Type
Device
Intervention Name(s)
PROPEL Mini Sinus Implant.
Intervention Description
Placement of sinus implant following frontal sinus surgery
Intervention Type
Procedure
Intervention Name(s)
Sinus Surgery alone
Intervention Description
Sinus surgery only, without implant placement
Intervention Type
Device
Intervention Name(s)
Propel Nova Sinus Implant
Other Intervention Name(s)
PROPEL contour Sinus Implant
Intervention Description
Placement of sinus implant following frontal sinus surgery
Primary Outcome Measure Information:
Title
Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort)
Description
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).
Time Frame
Day 30
Title
Percent of Sinuses That Require Post-operative Interventions (Propel Nova Cohort)
Description
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).
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Need for Post-operative Interventions (Propel Mini Cohort)
Description
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).
Time Frame
Day 30
Title
Need for Surgical Interventions (Propel Mini Cohort)
Description
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 Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted) Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted) Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)
Time Frame
Day 30
Title
Inflammation (Propel Mini Cohort)
Description
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.
Time Frame
Day 30
Title
Occlusion/Restenosis (Propel Mini Cohort)
Description
Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows: 0=Patent Restenosed/Partially Occluded Occluded
Time Frame
Day 30
Title
Need for Post-operative Interventions (Propel Nova Cohort)
Description
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).
Time Frame
Day 30
Title
Need for Surgical Interventions (Propel Nova Cohort)
Description
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 Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted) Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted) Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)
Time Frame
Day 30
Title
Inflammation (Propel Nova Cohort)
Description
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.
Time Frame
Day 30
Title
Occlusion/Restenosis (Propel Nova Cohort)
Description
Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows: 0=Patent Restenosed/Partially Occluded Occluded
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy L. Smith, MD, MPH
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amber U. Luong, MD, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sacramento Ear, Nose and Throat
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Breathe Clear Institute of Sinus and Allergy Relief
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
The Connecticut Center for Advanced ENT Care
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Facility Name
George Washington University Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20006
Country
United States
Facility Name
ENT of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Advanced ENT and Allergy
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Albany ENT and Allergy
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
East Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27363723
Citation
Smith TL, Singh A, Luong A, Ow RA, Shotts SD, Sautter NB, Han JK, Stambaugh J, Raman A. Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope. 2016 Dec;126(12):2659-2664. doi: 10.1002/lary.26140. Epub 2016 Jul 1. Erratum In: Laryngoscope. 2020 Mar;130(3):836.
Results Reference
result
PubMed Identifier
29098299
Citation
Luong A, Ow RA, Singh A, Weiss RL, Han JK, Gerencer R, Stolovitzky JP, Stambaugh JW, Raman A. Safety and Effectiveness of a Bioabsorbable Steroid-Releasing Implant for the Paranasal Sinus Ostia: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Jan;144(1):28-35. doi: 10.1001/jamaoto.2017.1859. Epub 2017 Nov 2.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs