Chronic Rhinosinusitis (Diagnosis)EXPANDNCT04858802
A Clinical Evaluation of PROPEL® Contour Sinus Implant
A study testing PROPEL Contour Sinus Implant and Balloon Sinus Dilation Alone in people with Chronic Rhinosinusitis (Diagnosis), run by Intersect ENT at 14 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- PROPEL Contour Sinus Implant and Balloon Sinus Dilation Alone
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 14 sitesUnited States
- Study dates
- 12 May 2021to 20 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
ENT of Georgia
Atlanta, Georgia, 30342
ENT & Allergy Associate of Florida, LLC
Boca Raton, Florida, 33487
ENT & Allergy Associate of Florida, LLC
Boynton Beach, Florida, 33426
Ohio Sinus Institute
Dublin, Ohio, 43016
Fort Worth ENT & Sinus
Fort Worth, Texas, 76109
Collin County ENT
Frisco, Texas, 75034
Ascentist Physicians Group
Leawood, Kansas, 66211
Kentuckiana Ear, Nose & Throat PSC
Louisville, Kentucky, 40205
Advanced ENT & Allergy
Louisville, Kentucky, 40220
ENT Associates of Texas
McKinney, Texas, 75070
Madison ENT
New York, New York, 10016
Sacramento ENT/DaVinci Research, LLC
Sacramento, California, 95815
Alamo ENT Associates
San Antonio, Texas, 78258
San Francisco Otolaryngology
San Francisco, California, 94108
About this study
Official title: 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)
Read the 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.
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Being tested
- PROPEL Contour Sinus Implant, Balloon Sinus Dilation Alone
- Keywords
- Frontal Sinus, Balloon Dilation
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROPEL Contour Sinus ImplantDevice
370 mcg mometasone furoate-coated sinus implant
Balloon Sinus Dilation AloneProcedure or surgery
No PROPEL Contour Sinus Implant
| Study group | Role | What they receive |
|---|---|---|
| PROPEL Contour Sinus Implant | Experimental | Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. Receives: 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. Receives: Procedure: Balloon Sinus Dilation Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 45
Secondary outcomes (17)
FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer
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.
Measured: Baseline, Day 45, and Day 180
CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer
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.
Measured: Days 45 and 180
CT FSO Minimum Diameter by Blinded Reviewer
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.
Measured: Days 45 and 180
CT Zinreich's Modified Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer
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.
Measured: Days 45 and 180
Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators
Need for post-operative intervention as determined by clinical investigators per endoscopy.
Measured: Days 21, 45, 90 and 180
CT Cross-sectional Area of FSO by Blinded Reviewer
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.
Measured: Day 180
CT Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer
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.
Measured: Days 45 and 180
CT Lund-Mackay Score for the Frontal Sinus by Clinical Investigators
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.
Measured: Days 45 and 180
Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators
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.
Measured: Days 21, 45, 90 and 180
Inflammation Score in the Frontal Recess/FSO by Clinical Investigators
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.
Measured: Days 21, 45, 90 and 180
Polypoid Edema in the Frontal Recess/FSO by Clinical Investigators
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.
Measured: Days 21, 45, 90 and 180
Adhesion/Scarring Grade in the Ethmoid Sinus by Clinical Investigators
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.
Measured: Day 21, 45, 90, and 180
Polyp Grade in the Ethmoid Sinus by Clinical Investigators
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.
Measured: Days 21, 45, 90 and 180
CRS Side-specific Symptom Score by Subject
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.
Measured: Days 21, 45, 90 and 180
SNOT-22 Score by Subject
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.
Measured: Day 180
RSI Score by Subject
Subject-reported outcome of RSI score.
The Rhinosinusitis Symptom Inventory (RSI) scale ranges from 0 to 60. Higher scores indicate a worse outcome.
Measured: Day 180
Implant Delivery Success by Clinical Investigators
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start12 May 2021
- Primary completion10 Feb 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intersect ENT
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858802
- Sponsor's protocol ID
- P500-1220
- Acronym
- EXPAND
- Status last verified
- Mar 2023
- First submitted
- 21 Apr 2021
- Last updated
- 21 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EXPAND Study: A Clinical Evaluation of PROPEL® Contour Sinus Implant Placement in the Frontal Sinus Ostium Following In-office Bilateral Balloon Dilation
- ClinicalTrials.gov ID
- NCT04858802
- Acronym / sponsor ID
- EXPAND / P500-1220
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Keywords
- Frontal Sinus, Balloon Dilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Intersect ENTIndustry (pharma, biotech, devices)
- Study start
- 12 May 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Posted 21 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PROPEL Contour Sinus Implant | Experimental | Device: PROPEL Contour Sinus ImplantFollowing successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side. |
| Balloon Sinus Dilation Alone | Active comparator | Procedure: Balloon Sinus Dilation AloneFollowing successful in-office bilateral balloon dilation, placement of no implant on the contralateral side. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROPEL Contour Sinus Implant370 mcg mometasone furoate-coated sinus implant | Device | PROPEL Contour Sinus Implant |
| Balloon Sinus Dilation AloneNo PROPEL Contour Sinus Implant | Procedure or surgery | Balloon Sinus Dilation Alone |
Primary outcome
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.
17 secondary outcomes
FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer
Time frame: Baseline, Day 45, and Day 180
CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer
Time frame: Days 45 and 180
CT FSO Minimum Diameter by Blinded Reviewer
Time frame: Days 45 and 180
CT Zinreich's Modified Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer
Time frame: Days 45 and 180
Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators
Time frame: Days 21, 45, 90 and 180
CT Cross-sectional Area of FSO by Blinded Reviewer
Time frame: 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 by Clinical Investigators
Time frame: Days 45 and 180
Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators
Time frame: Days 21, 45, 90 and 180
Inflammation Score in the Frontal Recess/FSO by Clinical Investigators
Time frame: Days 21, 45, 90 and 180
Polypoid Edema in the Frontal Recess/FSO by Clinical Investigators
Time frame: Days 21, 45, 90 and 180
Adhesion/Scarring Grade in the Ethmoid Sinus by Clinical Investigators
Time frame: Day 21, 45, 90, and 180
Polyp Grade in the Ethmoid Sinus by Clinical Investigators
Time frame: Days 21, 45, 90 and 180
CRS Side-specific Symptom Score by Subject
Time frame: Days 21, 45, 90 and 180
SNOT-22 Score by Subject
Time frame: Day 180
RSI Score by Subject
Time frame: Day 180
Implant Delivery Success by Clinical Investigators
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROPEL Contour Sinus Implant and Balloon Sinus Dilation Alone in people with Chronic Rhinosinusitis (Diagnosis), run by Intersect ENT at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in FSO Patency by Blinded Reviewer (time frame: Day 45). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.