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

• ClinicalTrials.gov Identifier: NCT02266810
• Recruitment Status: Completed
• First Posted: October 17, 2014
• Results First Posted: October 6, 2017
• Last Update Posted: August 15, 2018
• Sponsor: Intersect ENT
• Collaborator: Advance Research Associates
• Information provided by (Responsible Party): Intersect ENT

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.

Condition or disease	Intervention/treatment	Phase
Chronic Sinusitis	Device: PROPEL Mini Sinus Implant.; Procedure: Sinus Surgery alone; Device: Propel Nova Sinus Implant	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Intra-patient control
• Masking: Double (Participant, Outcomes Assessor)
• 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
• Study Start Date: September 2014
• Actual Primary Completion Date: April 2016
• Actual Study Completion Date: October 2016

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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).

2. 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 :

1. 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).

2. 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)
3. 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.
4. 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
5. 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).

6. 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)
7. 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.
8. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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, 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 of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Intersect ENT
• ClinicalTrials.gov Identifier: NCT02266810
• Other Study ID Numbers: P500-0514
• First Posted: October 17, 2014
• Results First Posted: October 6, 2017
• Last Update Posted: August 15, 2018
• Last Verified: October 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Sinusitis; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Mometasone Furoate; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents