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

NCT02266810 | Completed Phase 3 Results FDA Device

• 1 other identifier: P500-0514
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 10

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.

Conditions

Chronic Sinusitis

Outcome Measures

Primary Outcomes (2)

• 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).

  Day 30

• 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).

  Day 30

Secondary Outcomes (8)

• Need for Post-operative Interventions (Propel Mini Cohort)

  Day 30

• Need for Surgical Interventions (Propel Mini Cohort)

  Day 30

• Inflammation (Propel Mini Cohort)

  Day 30

• Occlusion/Restenosis (Propel Mini Cohort)

  Day 30

• Need for Post-operative Interventions (Propel Nova Cohort)

  Day 30

Study Arms (4)

PROPEL Mini Sinus Implant

EXPERIMENTAL

Propel Mini placed in frontal sinus opening following ESS

Device: PROPEL Mini Sinus Implant.

Sinus Surgery alone: cohort 1

ACTIVE COMPARATOR

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

Procedure: Sinus Surgery alone

PROPEL Nova Sinus Implant

EXPERIMENTAL

Propel Nova placed in frontal sinus opening following ESS

Device: Propel Nova Sinus Implant

Sinus Surgery alone: cohort 2

ACTIVE COMPARATOR

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

Procedure: Sinus Surgery alone

Interventions

PROPEL Mini Sinus Implant. DEVICE

Placement of sinus implant following frontal sinus surgery

PROPEL Mini Sinus Implant

Sinus Surgery alone PROCEDURE

Sinus surgery only, without implant placement

Sinus Surgery alone: cohort 1; Sinus Surgery alone: cohort 2

Propel Nova Sinus Implant DEVICE

Placement of sinus implant following frontal sinus surgery

Also known as: PROPEL contour Sinus Implant

PROPEL Nova Sinus Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intersect ENT: lead
• Advance Research Associates: collaborator

Study Sites (10)

Sacramento Ear, Nose and Throat

Sacramento, California, 95815, United States

Location

Breathe Clear Institute of Sinus and Allergy Relief

Torrance, California, 90503, United States

Location

The Connecticut Center for Advanced ENT Care

Norwalk, Connecticut, 06851, United States

Location

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20006, United States

Location

ENT of Georgia

Atlanta, Georgia, 30342, United States

Location

Advanced ENT and Allergy

Louisville, Kentucky, 40207, United States

Location

Albany ENT and Allergy

Albany, New York, 12206, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

East Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Related Publications (2)

• 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.

  PMID: 27363723 RESULT

• 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.

  PMID: 29098299 DERIVED

Results Point of Contact

• Title: James Stambaugh (VP, Clinical Affairs)
• Organization: Intersect ENT

jstambaugh@intersectent.com

650-641-2103

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intra-patient control

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: October 17, 2014
• Study Start: September 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 15, 2018
• Results First Posted: October 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)