A Clinical Evaluation of PROPEL® Contour Sinus Implant (EXPAND)

March 31, 2023 updated by: Intersect ENT

The EXPAND Study: A Clinical Evaluation of PROPEL® Contour Sinus Implant Placement in the Frontal Sinus Ostium Following In-office Bilateral Balloon Dilation

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)

Study Overview

Detailed Description

A post-market, randomized, intra-patient controlled, blinded multicenter study with 80 randomized subjects at up to 20 study centers.

After successful in-office bilateral balloon dilation of the frontal sinus ostium (FSO) using the VenSure™ Nav Balloon Device and Fiagon Cube Navigation System, patients will be randomized to receive one PROPEL Contour Sinus Implant on one side while the contralateral side serves as the control.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Sacramento, California, United States, 95815
        • Sacramento ENT/DaVinci Research, LLC
      • San Francisco, California, United States, 94108
        • San Francisco Otolaryngology
    • Florida
      • Boca Raton, Florida, United States, 33487
        • ENT & Allergy Associate of Florida, LLC
      • Boynton Beach, Florida, United States, 33426
        • ENT & Allergy Associate of Florida, LLC
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • ENT of Georgia
    • Kansas
      • Leawood, Kansas, United States, 66211
        • Ascentist Physicians Group
    • Kentucky
      • Louisville, Kentucky, United States, 40220
        • Advanced ENT & Allergy
      • Louisville, Kentucky, United States, 40205
        • Kentuckiana Ear, Nose & Throat PSC
    • New York
      • New York, New York, United States, 10016
        • Madison ENT
    • Ohio
      • Dublin, Ohio, United States, 43016
        • Ohio Sinus Institute
    • Texas
      • Fort Worth, Texas, United States, 76109
        • Fort Worth ENT & Sinus
      • Frisco, Texas, United States, 75034
        • Collin County ENT
      • McKinney, Texas, United States, 75070
        • ENT Associates of Texas
      • San Antonio, Texas, United States, 78258
        • Alamo ENT Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patient is 18 years of age or older.
  2. Patient is willing and able to comply with protocol requirements.
  3. Patient has confirmed diagnosis of CRS per International Consensus Statement on Allergy and Rhinology, Rhinosinusitis 2021 (ICAR:RS) guidelines.
  4. 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.
  5. 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

Exclusion Criteria:

  1. Patient has structural obstruction that precludes endoscopic visualization of one or both FSOs prior to implant placement.
  2. Expanded amount of ethmoid sinonasal polyps extending beyond the middle meatus (grade > 2) unless reduced 30 days prior to the baseline procedure
  3. Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or other conditions.
  4. Known history of allergy or intolerance to corticosteroids or mometasone furoate.
  5. Patients with a known hypersensitivity to lactide, glycolide or caprolactone copolymers.
  6. 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.
  7. Patients with monopolar pacemakers (older designs, with lower resistance to interference) or ICD's (implantable cardioverter defibrillator).
  8. Patients with implantable, body worn devices such as insulin pumps.
  9. Evidence of purulence coming from paranasal sinuses or ostiomeatal complex.
  10. Clinical evidence of acute bacterial sinusitis or invasive fungal sinusitis (e.g. bone erosion on prior CT scan, necrotic sinus tissue).
  11. Active viral illness (e.g., flu, shingles).
  12. Use of parenteral or injected steroids (e.g. Kenalog) 30 days prior to the baseline procedure.
  13. Use of oral steroids, budesonide or other sinus steroid irrigations/rinses or drops, nebulized steroids administered nasally 14 days prior to baseline procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PROPEL Contour Sinus Implant
Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.
370 mcg mometasone furoate-coated sinus implant
Active Comparator: Balloon Sinus Dilation Alone
Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.
No PROPEL Contour Sinus Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in FSO Patency by Blinded Reviewer
Time Frame: Day 45
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer
Time Frame: Baseline, Day 45, and Day 180
FSO cross-sectional area change from baseline to Day 45 and change from baseline to Day 180 per CT assessment performed by an independent, blinded reviewer. FSO cross-sectional area was measured via computer-assisted segmentation of CT images.
Baseline, Day 45, and Day 180
CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer
Time Frame: Days 45 and 180
FSOT, referring to the region of the frontal sinus surrounding the FSO, bordered superiorly by the frontal infundibulum and inferiorly by the frontal recess, is assessed by blinded reviewer. FSOT volume was measured via computer-assisted segmentation of CT images.
Days 45 and 180
CT FSO Minimum Diameter by Blinded Reviewer
Time Frame: Days 45 and 180
CT FSO minimum diameter assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. FSO minimum diameter was measured via computer-assisted segmentation of CT images.
Days 45 and 180
CT Zinreich's Modified Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer
Time Frame: Days 45 and 180

CT Zinreich's modified Lund-Mackay score for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses.

Zinreich's modified Lund-Mackay scale ranges from 0 to 5. Higher scores indicate a worse outcome.

Days 45 and 180
Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators
Time Frame: Days 21, 45, 90 and 180
Need for post-operative intervention as determined by clinical investigators per endoscopy.
Days 21, 45, 90 and 180
CT Cross-sectional Area of FSO by Blinded Reviewer
Time Frame: Day 180
CT cross-sectional area of FSO assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. Cross-sectional area of FSO was measured via computer-assisted segmentation of CT images.
Day 180
CT Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer
Time Frame: Days 45 and 180

CT Lund-Mackay score for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses.

The Lund-Mackay scale ranges from 0 to 2. Higher scores indicate a worse outcome.

Days 45 and 180
CT Lund-Mackay Score for the Frontal Sinus by Clinical Investigators
Time Frame: Days 45 and 180

CT Lund-Mackay for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses.

The Lund-Mackay scale ranges from 0 to 2. Higher scores indicate a worse outcome.

Days 45 and 180
Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators
Time Frame: Days 21, 45, 90 and 180

Endoscopic grading of adhesion/scarring grade in the frontal recess/FSO by clinical investigators.

The adhesion/scarring grade in the frontal recess/FSO scale ranges from 0 to 4. Higher scores indicate a worse outcome.

Days 21, 45, 90 and 180
Inflammation Score in the Frontal Recess/FSO by Clinical Investigators
Time Frame: Days 21, 45, 90 and 180

Endoscopic grading of inflammation score in the frontal recess/FSO by clinical investigators.

Inflammation score in the frontal recess/FSO ranges from 0 to 100. Higher scores indicate a worse outcome.

Days 21, 45, 90 and 180
Polypoid Edema in the Frontal Recess/FSO by Clinical Investigators
Time Frame: Days 21, 45, 90 and 180

Endoscopic grading of polypoid edema in the frontal recess/FSO by clinical investigators.

Polypoid edema in the frontal recess/FSO scale ranges from 0 to 3. Higher scores indicate a worse outcome.

Days 21, 45, 90 and 180
Adhesion/Scarring Grade in the Ethmoid Sinus by Clinical Investigators
Time Frame: Day 21, 45, 90, and 180

Endoscopic grading of adhesion/scarring grade in the ethmoid sinus by clinical investigators.

The adhesion/scarring grade in the ethmoid sinus scale ranges from 0 to 4. Higher scores indicate a worse outcome.

Day 21, 45, 90, and 180
Polyp Grade in the Ethmoid Sinus by Clinical Investigators
Time Frame: Days 21, 45, 90 and 180

Endoscopic grading of polyp grade in the ethmoid sinus by clinical investigators.

Polyp grade in the ethmoid sinus scale ranges from 0 to 3. Higher scores indicate a worse outcome.

Days 21, 45, 90 and 180
CRS Side-specific Symptom Score by Subject
Time Frame: Days 21, 45, 90 and 180

Subject-reported outcome of chronic rhinosinusitis (CRS) side-specific symptom score.

The chronic rhinosinusitis side-specific symptom score scale ranges from 0 to 30. Higher scores indicate a worse outcome.

Days 21, 45, 90 and 180
SNOT-22 Score by Subject
Time Frame: Day 180

Subject-reported outcome of SNOT-22 score.

The Sino-Nasal Outcome Test, 22 item (SNOT-22) is a validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a 6-point scale, ranging from a score of 0 ("no problem") to 5 ("problem as bad as it can be"). The maximum total score for all symptoms is equal to 110.

Higher scores indicate a worse outcome.

Day 180
RSI Score by Subject
Time Frame: Day 180

Subject-reported outcome of RSI score.

The Rhinosinusitis Symptom Inventory (RSI) scale ranges from 0 to 60. Higher scores indicate a worse outcome.

Day 180
Implant Delivery Success by Clinical Investigators
Time Frame: Baseline
Number of subjects who underwent successful access and deployment of the PROPEL Contour Sinus Implant into the FSO. Delivery is considered successful if the procedure concludes with correct implant placement on the intended side, even if a second attempt to place the implant is necessary. An attempted deployment occurs when the investigator introduces the delivery system into the subject's nostril with the intent of placing an implant.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2021

Primary Completion (Actual)

February 10, 2022

Study Completion (Actual)

June 20, 2022

Study Registration Dates

First Submitted

April 21, 2021

First Submitted That Met QC Criteria

April 21, 2021

First Posted (Actual)

April 26, 2021

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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