A Clinical Evaluation of PROPEL® Contour Sinus Implant

NCT04858802 | Completed Results FDA Device

• 1 other identifier: P500-1220
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 14

Brief Summary

The objective of this study is to evaluate the efficacy of PROPEL Contour placement following an in-office frontal sinus balloon dilation (SBD) in patients with chronic rhinosinusitis (CRS)

Conditions

Chronic Rhinosinusitis (Diagnosis)

Keywords

Frontal Sinus; Balloon Dilation

Outcome Measures

Primary Outcomes (1)

• Difference in FSO Patency by Blinded Reviewer

  Side-to-side difference in frontal sinus ostium (FSO) patency at Day 45 based on cross-sectional area of FSO by computed tomography (CT) measurements performed by an independent, blinded reviewer. Cross-sectional area of FSO was measured via computer-assisted segmentation of CT images.

  Day 45

Secondary Outcomes (17)

• FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer

  Baseline, Day 45, and Day 180

• CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer

  Days 45 and 180

• CT FSO Minimum Diameter by Blinded Reviewer

  Days 45 and 180

• CT Zinreich's Modified Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer

  Days 45 and 180

• Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators

  Days 21, 45, 90 and 180

Study Arms (2)

PROPEL Contour Sinus Implant

EXPERIMENTAL

Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.

Device: PROPEL Contour Sinus Implant

Balloon Sinus Dilation Alone

ACTIVE COMPARATOR

Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.

Procedure: Balloon Sinus Dilation Alone

Interventions

PROPEL Contour Sinus Implant DEVICE

370 mcg mometasone furoate-coated sinus implant

PROPEL Contour Sinus Implant

Balloon Sinus Dilation Alone PROCEDURE

No PROPEL Contour Sinus Implant

Balloon Sinus Dilation Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is 18 years of age or older.
• Patient is willing and able to comply with protocol requirements.
• Patient has confirmed diagnosis of CRS per International Consensus Statement on Allergy and Rhinology, Rhinosinusitis 2021 (ICAR:RS) guidelines.
• Bilateral disease in the frontal sinuses (Lund-Mackay CT score of ≥1 on each side) on CT scan within 90 days prior to the baseline.
• A successfully completed in-office bilateral balloon dilation of the FSO with no complication on either side that, in the opinion of the clinical investigator is amenable for PROPEL Contour Sinus Implant placement in both FSO

You may not qualify if:

• Patient has structural obstruction that precludes endoscopic visualization of one or both FSOs prior to implant placement.
• Expanded amount of ethmoid sinonasal polyps extending beyond the middle meatus (grade \> 2) unless reduced 30 days prior to the baseline procedure
• Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or other conditions.
• Known history of allergy or intolerance to corticosteroids or mometasone furoate.
• Patients with a known hypersensitivity to lactide, glycolide or caprolactone copolymers.
• Patients with electronic devices in direct connection to the brain or the nervous system such as implantable neurostimulators (e.g. deep brain stimulation), programmable cerebrospinal fluid (CSF) shunts.
• Patients with monopolar pacemakers (older designs, with lower resistance to interference) or ICD's (implantable cardioverter defibrillator).
• Patients with implantable, body worn devices such as insulin pumps.
• Evidence of purulence coming from paranasal sinuses or ostiomeatal complex.
• Clinical evidence of acute bacterial sinusitis or invasive fungal sinusitis (e.g. bone erosion on prior CT scan, necrotic sinus tissue).
• Active viral illness (e.g., flu, shingles).
• Use of parenteral or injected steroids (e.g. Kenalog) 30 days prior to the baseline procedure.
• Use of oral steroids, budesonide or other sinus steroid irrigations/rinses or drops, nebulized steroids administered nasally 14 days prior to baseline procedure.

Sponsors & Collaborators

• Intersect ENT: lead

Study Sites (14)

Sacramento ENT/DaVinci Research, LLC

Sacramento, California, 95815, United States

Location

San Francisco Otolaryngology

San Francisco, California, 94108, United States

Location

ENT & Allergy Associate of Florida, LLC

Boca Raton, Florida, 33487, United States

Location

ENT & Allergy Associate of Florida, LLC

Boynton Beach, Florida, 33426, United States

Location

ENT of Georgia

Atlanta, Georgia, 30342, United States

Location

Ascentist Physicians Group

Leawood, Kansas, 66211, United States

Location

Kentuckiana Ear, Nose & Throat PSC

Louisville, Kentucky, 40205, United States

Location

Advanced ENT & Allergy

Louisville, Kentucky, 40220, United States

Location

Madison ENT

New York, New York, 10016, United States

Location

Ohio Sinus Institute

Dublin, Ohio, 43016, United States

Location

Fort Worth ENT & Sinus

Fort Worth, Texas, 76109, United States

Location

Collin County ENT

Frisco, Texas, 75034, United States

Location

ENT Associates of Texas

McKinney, Texas, 75070, United States

Location

Alamo ENT Associates

San Antonio, Texas, 78258, United States

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Per study eligibility criteria, participants were required to have a Lund-Mackay score ≥1 on both frontal sinus sides at baseline as assessed by clinical investigators. Only roughly half of participants met this criteria per independent, blinded review. This may confound results, as a Lund-Mackay score of ≥1 indicates CT evidence of sinonasal inflammation and is recommended as a precondition for surgery in the International Consensus Statement on Allergy and Rhinology: Rhinosinusitis 2021.

Results Point of Contact

• Title: Xiaomin Deng
• Organization: Medtronic plc

Xiaomin.deng@medtronic.com

707-566-1311

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intrapatient control in which eligible subjects will receive the PROPEL Contour Sinus Implant (Treatment) on one side, and no implant (Control) on the contralateral side.

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 26, 2021
• Study Start: May 12, 2021
• Primary Completion: February 10, 2022
• Study Completion: June 20, 2022
• Last Updated: April 21, 2023
• Results First Posted: April 21, 2023

Record last verified: 2023-03

Locations

US (14)