The EXPAND Study: A Clinical Evaluation of PROPEL® Contour Sinus Implant Placement in the Frontal Sinus Ostium Following In-office Bilateral Balloon Dilation
Phase: NA
Conditions: Chronic Rhinosinusitis (Diagnosis)
Sponsor: Intersect ENT

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Clinical Study Protocol P500-1220 (The EXPAND Study) 
Doc# CP-00030 Rev. 5.0, 26 May 2022 
CLINICAL STUDY PROTOCOL 
1 
TITLE PAGE 
 
CONFIDENTIALITY STATEMENT 
 
Study Title 
The EXPAND Study: A Clinical Evaluation of PROPEL® Contour Placement 
Following In-Office Frontal Sinus Balloon Dilation 
Protocol Number 
P500-1220 
ClinicalTrials.gov ID 
NCT04858802 
Study Devices 
PROPEL Contour Sinus Implant (mometasone furoate, 370 mcg) 
VenSure™ Nav Balloon Device 
Cube Navigation System 
Study Design 
Post-market, randomized, intra-patient controlled, blinded, multicenter trial 
Sponsor’s Name and 
Address 
Intersect ENT, Inc. 
1555 Adams Drive 
Menlo Park, CA 94025 USA 
Tel: +1 650-641-2100  
Fax: +1 650-641-2053 
National Principal 
Investigator 
Boris Karanfilov, MD 
Ohio Sinus Institute 
5378 Avery Road 
Dublin, Ohio 43016  
Tel: +1 614-771-9871 
bk@ohiosinus.com  
Data Management and 
Study Monitoring 
Intersect ENT, Inc. 
Biostatistics and Data 
Analysis 
Intersect ENT, Inc. 
 
This study will be conducted under the guidance of the International Council on Harmonization (ICH) E6(R2) Good 
Clinical Practice: Integrated Addendum to ICH E6(R1) March 2018 (abbreviated as ICH E6(R2)); FDA’s Good Clinical 
Practice (GCP) regulations for medical devices; ISO’s Clinical investigation of medical devices for human subjects - 
Good clinical practice (ISO 14155:2020) and other applicable local and federal regulations. 
 
 
 
This document is the property of Intersect ENT, Inc. The document is highly confidential and is to be used only in 
connection with matters authorized by a senior representative of Intersect ENT, and no part of it is to be disclosed to a 
third party without prior written permission from Intersect ENT. 
The study-related COVID-19 contingency measures to assure the safety of study subjects, maintain compliance with 
GCP, and minimize risks to study integrity for the duration of the COVID-19 pandemic are detailed in Section 21. 

 
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Clinical Study Protocol P500-1220 (The EXPAND Study) 
Doc# CP-00030 Rev. 5.0, 26 May 2022 
2 
REVISION HISTORY 
4.0 
03-SEP-2021 
 
Updated study title 
 
Added ClinicalTrials.gov identifier 
 
Updated study design includes increased number of study centers from 
15 to 20, changed Day 90 phone visit to in-person visit and added 
Revision 
Revision Date 
Reason for Revision 
1.0 
26-FEB-2021 
Initial Release 
2.0 
18-MAR-2021 
 
Updated study devices in protocol summary for alignment. 
 
Clarified primary efficacy endpoint measurement. 
 
Modified inclusion criteria regarding successful in-office balloon 
dilation of bilateral FSO. 
 
Modified eligibility criteria and added baseline procedure to allow for 
optional maxillary/sphenoid sinus dilation with a commercially 
available balloon sinuplasty device, if clinically necessary, prior to 
dilating the frontal sinuses. 
 
Added exclusion criteria to align with contraindications noted in Cube 
Navigation System IFU. 
 
Removed endoscopic confirmation of bilateral frontal stenosis from 
schedule of assessments. 
 
Aligned concomitant medications noted in Protocol Summary and 
Concomitant Medication sections. 
 
Added AE severity guidelines. 
 
Clarified potential risks section. 
3.0 
30-APR-2021 
 
Realigned Sec 11.3 to defer to Core Laboratory Imaging Guidelines 
and removed Volume Evaluation from title of Sec 11.3  
 
Realigned Sec 11.4 to defer to Core Laboratory Reading Guidelines 
which specifies the sinus areas for evaluation, including the Contour 
area to measure the Primary Endpoint 
 
Removed Appendix 2: Cone Beam CT Imaging Parameters 
 
Included Disposable Inflation Device in applicable sections 
 
Added “Device” after VenSure Nav Balloon throughout the document 
 
Changed “patient” to “subject” throughout document 
 
Changed Day 1 to Day 0 for Baseline/Procedure in Sec 5.0 Study Flow 
Diagram 
 
Sec 3.0 Terms: Replaced ISO 14155:2011 definition of “Use Error” 
with updated definition and notes from ISO 14155:2020 
 
Sec 3.0 Terms: Removed ‘compatible accessory device’ from the 21 
CFR 803 definition of “Device Malfunction” because it is not 
applicable in this study. 
 
Sec 4.0 Aligned Study Title with Objective, added “in-office” and 
“bilateral” to Objective 
 
Sec 10.4 subparagraph Bilateral Balloon Dilation of the FSO removed 
“includes guidewires” as they are not included in IFU 
 
Phrase “Primary endpoint will be released after all eligible subjects 
have completed Day 45 CT scan.” Moved from Sec 9.2.1 to Statistics 
Sec 16.6 Intent-to-Treat (ITT) Population 

 
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Clinical Study Protocol P500-1220 (The EXPAND Study) 
Doc# CP-00030 Rev. 5.0, 26 May 2022 
patient symptom questionnaires (SNOT-22, RSI and CRS side-specific 
symptoms) at baseline and follow-up visit, requirement for endoscopic 
evaluation and video recording prior to the baseline procedure and at 
each follow-up visit 
 
Updated Schedule of Assessments Study and Flow Diagram to reflect 
on the updated study design 
 
Removed redundant and non-applicable eligibility criteria 
 
Updated primary and secondary endpoints 
 
Clarified investigator’s standard protocol used for nasal endoscopy and 
procedures may be used; examples of anesthesia removed 
 
Updated optional in-office baseline procedures allowed  
 
Removed restriction that medically necessary maxillary and sphenoid 
sinus dilation must use a separate commercially available device 
 
Added that CT scan may need to be redone if it does not meet the Cube 
Navigation System Requirements 
 
Sec. 13 Clarified the acquisition and measurements of CT scans 
 
Clarified training process 
 
Sec. 17 Added indeterminate as a relationship classification for AEs 
and AE expectedness section 
 
Sec. 18  Indicated that the detailed analysis plan for primary /secondary 
endpoints will be described in the statistically analysis plan 
 
Added Sec. 21 with COVID-19 Contingency Measures  
 
Made minor clarifications, edits and editorial changes throughout 
5.0 
20-MAY-2022 
 
Sec. 3 added FSOT abbreviation 
 
Sec. 4 added FSOT definition 
 
Sec. 5 and 9.2 replaced FSO maximum diameter with FSO minimum 
diameter, added FSOT volume to secondary endpoints, and specified 
frontal score for Lund-Mackay and Zinreich’s modified Lund-Mackay 
 
Sec 5 and 9.3 moved health-economic measures and patient satisfaction 
from secondary endpoints to exploratory endpoints 
 
Sec. 9.1 and 13.2 updated wording of the primary efficacy endpoint to 
align with CP-00038 
 
Sec. 12.5 made optional assessments at unscheduled visits 
 
Sec. 18.6 updated definition of PTE population and added examples of 
major procedural protocol deviations 
 
Added CP-00038 Radiographic Evaluation Protocol for P500-1220 
(The EXPAND Study) to references 
 
Made minor clarifications, edits and editorial changes throughout 
 

 
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Clinical Study Protocol P500-1220 (The EXPAND Study) 
Doc# CP-00030 Rev. 5.0, 26 May 2022 
TABLE OF CONTENTS 
1 
TITLE PAGE ..................................................................................................................... 1 
2 
REVISION HISTORY ...................................................................................................... 2 
3 
LIST OF ABBREVIATIONS ........................................................................................... 7 
4 
DEFINITIONS OF TERMS ............................................................................................. 8 
5 
PROTOCOL SUMMARY .............................................................................................. 14 
6 
STUDY FLOW DIAGRAM ............................................................................................ 17 
7 
SCHEDULE OF ASSESSMENTS ................................................................................. 18 
8 
BACKGROUND INFORMATION ............................................................................... 19 
8.1 
Literature Review ..................................................................................................19 
8.2 
PROPEL Contour Sinus Implant ...........................................................................20 
9 
STUDY OBJECTIVE AND ENDPOINTS .................................................................... 20 
9.1 
Primary Efficacy Endpoint ....................................................................................21 
9.2 
Secondary Endpoints .............................................................................................21 
9.3 
Exploratory Endpoints ...........................................................................................22 
9.4 
Safety Measures .....................................................................................................22 
9.5 
Health-Economic Measures ...................................................................................22 
10 
STUDY DESIGN .............................................................................................................. 23 
11 
STUDY POPULATION .................................................................................................. 23 
11.1 
Inclusion Criteria ...................................................................................................23 
11.2 
Exclusion Criteria ..................................................................................................24 
11.3 
Subject Withdrawal ...............................................................................................25 
12 
SUBJECT TREATMENT AND STUDY PROCEDURES .......................................... 26 
12.1 
Pre-screening .........................................................................................................26 
12.2 
Informed Consent, Enrollment and Screening .......................................................26 
12.3 
Baseline/Procedure ................................................................................................27 
12.4 
Follow-Up ..............................................................................................................29 
12.5 
Unscheduled Visits ................................................................................................29 
13 
CT SCAN AND PRODUCT ACCOUNTABILITY...................................................... 30 
13.1 
Image Acquisition ..................................................................................................30 

 
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Clinical Study Protocol P500-1220 (The EXPAND Study) 
Doc# CP-00030 Rev. 5.0, 26 May 2022 
13.2 
Centralized Blinded Review ..................................................................................30 
13.3 
Product Accountability ..........................................................................................30 
14 
PRIOR AND CONCOMITANT MEDICATIONS....................................................... 30 
15 
MEDICAL AND SURGICAL INTERVENTIONS ...................................................... 31 
15.1 
Medical Intervention ..............................................................................................31 
15.2 
Surgical Intervention .............................................................................................31 
16 
ASSESSMENT OF SAFETY .......................................................................................... 32 
16.1 
Specification of Safety Parameters ........................................................................32 
16.2 
Classification of AEs .............................................................................................32 
16.3 
AE Adjudication ....................................................................................................34 
16.4 
Guidelines for AE Reporting .................................................................................34 
17 
RISK/BENEFIT ASSESSMENT .................................................................................... 35 
17.1 
Potential Risks .......................................................................................................36 
17.2 
Minimization of Anticipated Risks ........................................................................38 
17.3 
Potential Risks to Study Subject Confidentiality ...................................................38 
17.4 
Potential Benefits of Study Participation ...............................................................39 
17.5 
Risk/Benefit Conclusion ........................................................................................39 
18 
STATISTICAL CONSIDERATIONS ........................................................................... 39 
18.1 
Randomization .......................................................................................................39 
18.2 
Analysis of Primary Efficacy Endpoint .................................................................39 
18.3 
Analysis of Key Secondary Efficacy Endpoints ....................................................40 
18.4 
Analysis of Secondary and Exploratory Endpoints ...............................................40 
18.5 
Safety Measures .....................................................................................................40 
18.6 
Analysis Populations .............................................................................................40 
18.7 
Interim Analysis .....................................................................................................40 
19 
STUDY MANAGEMENT ............................................................................................... 40 
19.1 
Ethical Considerations ...........................................................................................41 
19.2 
Sponsor Responsibilities ........................................................................................41 
19.3 
Blinding .................................................................................................................41 
19.4 
Training ..................................................................................................................42 

 
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Clinical Study Protocol P500-1220 (The EXPAND Study) 
Doc# CP-00030 Rev. 5.0, 26 May 2022 
19.5 
Protocol Deviations ...............................................................................................42 
19.6 
Monitor Responsibilities ........................................................................................43 
19.7 
Data Management Responsibilities .......................................................................43 
19.8 
Investigator Responsibilities ..................................................................................44 
19.9 
Protection of Subject Confidentiality ....................................................................46 
19.10 Study Suspension or Early Termination ................................................................47 
19.11 Site Closeout ..........................................................................................................47 
19.12 Quality Assurance and Supervision by Authorities ...............................................47 
19.13 Approved ICF and Protection of Study Subject ....................................................48 
19.14 IRB Approval .........................................................................................................48 
19.15 Other Investigator Reports .....................................................................................48 
19.16 Final Clinical Study Report ...................................................................................49 
20 
PUBLICATION POLICY ............................................................................................... 49 
21 
COVID -19 CONTIGENCY MEASURES .................................................................... 49 
21.1 
Study Procedures During COVID-19 ....................................................................49 
21.2 
Contingency Measures for Study Management .....................................................50 
22 
REFERENCES ................................................................................................................. 52 
APPENDIX I:  LIST OF CORTICOSTEROID MEDICATIONS ........................................ 54 
 
 

 
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Clinical Study Protocol P500-1220 (The EXPAND Study) 
Doc# CP-00030 Rev. 5.0, 26 May 2022 
3 
LIST OF ABBREVIATIONS 
 
Abbreviation 
Expansion 
ADE 
adverse device effect 
AE 
adverse event 
ASADE 
anticipated serious adverse device effect 
CFR 
Code of Federal Regulations 
CIP 
clinical investigational plan 
COPD 
chronic obstructive pulmonary disease 
CRF 
case report form 
CRS 
chronic rhinosinusitis 
CSP 
clinical study protocol 
CSR 
clinical study report 
CT 
computed tomography 
EDC 
electronic data capture 
e.g. 
‘exempli gratia’ in Latin, meaning ‘for example’ 
ESS 
endoscopic sinus surgery 
et al 
‘et alia’ in Latin, meaning ‘and others’ 
FDA 
Food and Drug Administration 
FSO 
frontal sinus ostium/ostia 
FSOT 
frontal sinus outflow tract 
GCP 
good clinical practice 
ICF 
informed consent form 
ICH 
International Council on Harmonization 
i.e. 
‘id est’ in Latin, meaning ‘that is’ 
IFU 
instructions for use 
INCS 
intranasal corticosteroids 
IRB 
institutional review board 
ITT 
intent-to-treat 
MF 
mometasone furoate 
OS 
frontal sinus outflow narrowest diameter 
PTE 
per-treatment-evaluable 
RSI 
Rhinosinusitis Symptom Inventory 
SADE 
serious adverse device effect 
SAE 
serious adverse event 
SBD 
sinus balloon dilation 
SOP 
standard operating procedure 
UADE 
unanticipated adverse device effect 
USADE 
unanticipated serious adverse device effect 

 
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Clinical Study Protocol P500-1220 (The EXPAND Study) 
Doc# CP-00030 Rev. 5.0, 26 May 2022 
4 
DEFINITIONS OF TERMS 
Term 
Definition 
Adhesion/scarring grading scale 
for the ethmoid sinus 
Adhesion/scarring severity in the ethmoid sinus graded on a 5-
point scale as follows: 
 
0: None 
 
1:  Small but non-obstructing (no separation required) 
 
2: Obstructing, but easily separated 
 
3:  Dense and obstructing, separation difficult 
 
4:  Severe: complete adhesion of the middle turbinate to the lateral 
nasal wall 
Adhesion/scarring grading scale 
for the frontal sinus ostium/ostia 
(FSO) 
Adhesion/scarring in the FSO assessed 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) 
Adverse device effect (ADE) 
Adverse event related to the use of an investigational medical device. This 
definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or 
operation, or any malfunction of the investigational medical device. This 
definition also includes any event resulting from use error or from 
intentional misuse of the investigational medical device.  If a comparator 
medical device is used in the investigation, this definition also applies to 
ADEs of the comparator device. [ISO 14155:2020] 
Adverse event (AE) 
Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical sign(s) (including abnormal laboratory findings) in 
subjects, users or other persons, whether or not related to the 
investigational medical device and whether anticipated or unanticipated.   
This definition includes events related to the procedures involved. 
This definition also includes events related to the investigational medical 
device or any comparator device. For users or other persons, this 
definition is restricted to events related to the use of investigational 
medical devices or comparators. [ISO 14155:2020] 
Baseline 
Information and values collected during Screening and before initiation of 
the study treatment.  
Baseline procedure 
In-office, bilateral frontal sinus balloon dilation. 
Case report form (CRF) 
A printed, optical, or electronic document designed to record all of the 
protocol required information to be reported to the sponsor on each trial 
subject. [ISO 14155:2020] 
Chronic rhinosinusitis (CRS) 
Per the 2021 “International Consensus Statement on Allergy and 
Rhinology” definition, patient must have ≥ 12 weeks of: 
Two or more of the following symptoms: 
 
Nasal discharge (anterior/posterior) 

 
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Clinical Study Protocol P500-1220 (The EXPAND Study) 
Doc# CP-00030 Rev. 5.0, 26 May 2022 
 
Nasal blockage/obstruction/congestion 
 
Reduction/loss of smell 
 
Facial pressure/pain 
And one or more of the following findings: 
 
Evidence of inflammation on paranasal sinus examination or 
computed tomography 
 
Evidence of purulence coming from paranasal sinuses or ostiomeatal 
complex 
CRS side-specific symptom 
questionnaire 
Allows to evaluate each of the following 5 cardinal symptoms of CRS on 
the left and right side: 
 
Facial pain/pressure 
 
Facial congestion/fullness 
 
Nasal obstruction/blockage 
 
Discolored or pus nasal discharge or post-nasal drip 
 
Decreased sense of smell 
Each side is scored individually on a 6-point scale as follows: 
 
0: Absent  
 
1: Very mild 
 
2: Mild 
 
3: Moderate 
 
4: Severe 
 
5: Very severe 
Clinical Investigational Plan 
(CIP) or Clinical Study Protocol 
(CSP) 
Document that states the rationale, objectives, design and pre-specified 
analysis, methodology, organization, monitoring, conduct and record-
keeping of the clinical investigation [ISO 14155:2020] 
Device deficiency 
Inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, usability, safety or performance. Device deficiencies 
include malfunctions, use errors, and inadequacy in the information 
supplied by the manufacturer including labelling. This definition also 
includes device deficiencies related to the investigational medical device 
or the comparator.  [ISO 14155:2020]  
Device malfunction 
For an investigational medical device: Failure to perform in accordance 
with its intended purpose when used in accordance with the instructions 
for use or clinical investigation plan (CIP), or Investigators’ Brochure 
(IB). [ISO 14155:2020]  
Failure to meet its performance specifications or otherwise perform as 
intended. The intended performance of a device refers to the intended use 
for which the device is labeled or marketed. [21 CFR 803] 
Enrolled 
Subjects are considered enrolled upon signing the IRB-approved informed 
consent form.  
Frontal sinus ostia/ostium (FSO) 
Refers to the natural frontal sinus openings 
Frontal sinus outflow tract (FSOT) 
Refers to the region of the frontal sinus surrounding the FSO, bordered 
superiorly by the frontal infundibulum and inferiorly by the frontal recess 
Implant delivery success 
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 

 
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Clinical Study Protocol P500-1220 (The EXPAND Study) 
Doc# CP-00030 Rev. 5.0, 26 May 2022 
occurs when the investigator introduces the delivery system into the 
subject’s nostril with the intent of placing an implant.    
The proportion of successful deployments is defined as a fraction where 
the numerator is the number of successful deployments and the 
denominator is the number of sinuses in which a deployment was 
attempted.   
Inflammation score  
For the purpose of the endoscopic scoring method in this study, the term 
inflammation is a global descriptor that includes erythema, edema and/or 
polypoid changes. The inflammation present in the frontal recess/FSO is 
estimated visually based on the endoscopic examination on a scale 
ranging from 0 (no visible inflammation) to 100 (severe inflammation) 
involving extensive erythema, or polyposis 
Institutional Review Board (IRB)  
 
An independent body whose responsibility it is to review clinical 
investigations in order to protect the rights, safety and well-being of 
human subjects participating in a clinical investigation. The primary 
purpose of such review is to assure the protection of the rights, safety, and 
welfare of human subjects. The IRB should be established, operated, and 
function in conformance with 21 CFR 56.  
Intent-to-treat (ITT) population 
Consists of all randomized subjects and sinuses in whom the study 
implant in the target sinus was attempted. An attempt occurs when the 
physician introduces the delivery system into the subject’s nostril with the 
intent of implant placement.  
Lund-Mackay CT Staging System 
Assigns a value of 0 if the sinus is totally patent, 1 if it is partial opacified 
or 2 if it is completely opacified to each of the frontal, anterior ethmoid, 
posterior ethmoid, maxillary, and sphenoid sinus. The ostiomeatal 
complex (OMC) is scored either 0 or 2. The maximum score for each side 
is thus 12, with a total score determined out of 24. 
Patient satisfaction questionnaire 
Question to patient on how satisfied is he/she with the PROPEL Contour 
for treatment of CRS and whether  he/she would recommend the PROPEL 
Contour to a family member or a friend 
Per-treatment-evaluable (PTE) 
population 
Consists of all randomized subjects and sinuses that have received the 
assigned study implant in the target sinus, who have no major procedural 
protocol deviations and for whom follow-up data are available. 
Polyp grading scale for the 
ethmoid sinus 
Polyps originating from the ethmoid sinus assessed endoscopically and 
graded on an 8-point scale as follows:  
 0:  No visible sinonasal polyps 
 1:  Small amount of sinonasal polyps confined in middle meatus 
 1.5:  Small amount of sinonasal polyps confined in middle meatus 
with expanded amount of polypoid edema obstructing ≥ 25% of 
the ethmoid sinus cavity 
 2:  Expanded amount of sinonasal polyps confined in middle meatus 
 2.5:  Expanded amount of sinonasal polyps confined in middle meatus 
with expanded amount of polypoid edema obstructing ≥ 50% of 
the ethmoid sinus cavity 
 3:  Sinonasal polyps extending beyond middle meatus but not totally 
obstructing the nasal cavity 

 
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 3.5:  Sinonasal polyps extending beyond middle meatus with 
expanded amount of polypoid edema obstructing ≥ 75% of the 
ethmoid sinus cavity 
 4:  Sinonasal polyps completely obstructing the nasal cavity 
Polypoid edema in the FSO 
Polypoid edema in the frontal recess/FSO is assessed on a 4-point scale as 
follows:  
 
0: Normal mucosa, no visible polyps/mucosal edema  
 
1: Minimal amount of polyps/mucosal edema 
 
2: Moderate amount of polyps/polypoid edema 
 
3: Expanded amount of polyps/polypoid edema 
Rhinosinusitis Symptom Inventory 
(RSI) 
RSI is administered using a paper (reflective) questionnaire to assess the 
CRS symptoms: 5 key symptoms (facial pain/pressure, facial congestion/ 
fullness, nasal obstruction/blockage, nasal discharge or post-nasal drip, 
decreased sense of smell), 7 other symptoms (headache, halitosis, dental 
pain, cough, ear symptoms, fevers, and fatigue) on a 6-point scale of 0 to 
5, as follows:  
 
0: Absent 
 
1: Very mild 
 
2: Mild 
 
3: Moderate 
 
4: Severe 
 
5: Very severe  
The individual symptom scores were used to calculate 4 domain scores as 
follows: 
 
Nasal: sum of scores for nasal obstruction, rhinorrhea, sense of smell 
 
Facial: sum of scores for facial pain/pressure, facial congestion/ 
fullness, and headache 
 
Oropharyngeal: sum of scores for halitosis, dental pain, cough, and 
ear symptoms 
 
Systemic: sum of scores for fevers, and fatigue 
In addition, the RSI catalogs medication use (topical nasal corticosteroids, 
prescription antihistamines, and oral antibiotics), physician visits, and 
workdays missed due to CRS. 
Safety population 
Consists of all subjects and sinuses exposed to PROPEL Contour Sinus 
Implant.  This population will be used for all summaries of adverse 
events.  Any subjects enrolled in the study who are not exposed to the 
PROPEL Contour Sinus Implant will be summarized separately. 
Serious adverse device effect 
(SADE) 
An adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. If the nature, incidence, severity 
or outcome of a SADE has been identified in the device’s risk analysis 
report, it is considered an anticipated SADE (or ASADE) 
Serious adverse event (SAE) 
Adverse events are considered “serious” if, in the view of either the 
investigator or sponsor, they result in any the following outcomes: 
 
Death; or 
 
A life-threatening illness or injury; or 
 
Permanent impairment of a body structure or a body function; or 

 
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 
Inpatient hospitalization or prolongation of existing hospitalization; 
or 
 
Medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body 
function; or  
 
Fetal distress, fetal death, or a congenital anomaly/birth defect. 
Important medical events that may not result in death, be life-threatening, 
or require hospitalization may be considered serious when, based upon 
appropriate medical judgment, they may jeopardize the patient and may 
require medical or surgical intervention to prevent one of the outcomes 
listed in this definition. 
Planned hospitalization for a pre-existing condition, or a procedure 
required by the CIP/CSP, without serious deterioration in health, is not 
considered a serious adverse event. [ISO 14155:2020] 
Sino-Nasal Outcome Test (SNOT-
22) 
Validated, disease-specific, symptom-scoring instrument consisting of 22 
questions, each scored by patient on a 6-point scale as follows:  
 
0: No problem 
 
1: Very mild problem 
 
2:  Mild or slight problem 
 
3:  Moderate problem 
 
4:  Severe problem   
 
5: Problem as bad as it can be 
The maximum total score for all symptoms is equal to 110. 
Source data 
All information in original records and certified copies of original records 
of clinical findings, observations, or other activities in a clinical trial 
necessary for the reconstruction and evaluation of the trial.  
Source documents 
Original documents, data, and records. Printed, optical, or electronic 
documents containing source data.  
Subject 
An individual who participates in a clinical investigation  
Unanticipated adverse device 
effect (UADE) 
Any serious adverse effect on health or safety or any life-threatening 
problem or death caused by, or associated with, a device, if that effect, 
problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan or application, or any other 
unanticipated serious problem associated with a device that relates to the 
rights, safety, or welfare of subjects. [21 CFR 812]  
 
A UADE is comparable to an unexpected serious adverse device effect 
(USADE) as defined in ISO 14155:2020 (see definition below), although 
it doesn’t include an “S” for serious in the FDA’s acronym. NOTE: The 
occurrence of a diagnostic or elective surgical procedure for a pre-existing 
condition, unless the condition becomes more severe or increases in 
frequency because of the device, would not be considered an adverse 
device effect (ADE). 
Unanticipated serious adverse 
device effect (USADE) 
Any serious adverse device effect (SADE) which by its nature, incidence, 
severity or outcome has not been identified in the current version of the 
risk analysis report. [ISO 14155:2020; 21 CFR 812] 

 
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If the nature, incidence, severity or outcome of a SADE has been 
identified in the device’s risk analysis report, it is considered an 
anticipated SADE (or ASADE). 
Use error 
User action or lack of user action while using the medical device that 
leads to a different result than that intended by the manufacturer or 
expected by the user. 
Use error includes the inability of the user to complete a task. 
Use errors can result from a mismatch between the characteristics of the 
user, user interface, task or use environment. 
Users might be aware or unaware that a use error has occurred. 
An unexpected physiological response of the patient is not by itself 
considered a use error. 
A malfunction of a medical device that causes an unexpected result is not 
considered a use error. 
[ISO 14155:2020] 
Zinreich’s Modified Lund-Mackay 
Staging System 
Each sinus is assigned a score based on the percentage of opacification 
from mucosal thickening as follows: 
 
0: 0%  
 
1: 1% to 25% 
 
2: 26% to 50% 
 
3: 51% to 75% 
 
4: 76% to 99% 
 
5:   100% or completely occluded 
The ostiomeatal complex (OMC) is given a score of 0 if it is completely 
patent, 1 if it is partially obstructed, or 2 if it is completely obstructed. 
Similar to the Lund-Mackay system, each side is graded, and their sum is 
the total score out of maximum of 54. 

 
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Clinical Study Protocol P500-1220 (The EXPAND Study) 
Doc# CP-00030 Rev. 5.0, 26 May 2022 
5 
PROTOCOL SUMMARY 
Study Title 
The EXPAND Study:  A Clinical Evaluation of PROPELTM Contour Placement 
Following In-Office Frontal Sinus Balloon Dilation 
Objective 
To evaluate the efficacy of PROPEL Contour placement following an in-office frontal 
sinus balloon dilation (SBD) in patients with chronic rhinosinusitis (CRS) 
Study Devices 
PROPEL Contour (mometasone furoate, 370 mcg) 
VenSure™ Nav Balloon Device  
Cube Navigation System 
Study Design 
Post-market, randomized, intra-patient controlled, blinded, multicenter trial 
Subject Enrollment 
80 randomized subjects at up to 20 US study centers 
Treatment Assignment 
After successful in-office bilateral frontal SBD using the VenSure Nav Balloon Device 
and Cube Navigation System, subjects will be randomized to receive 1 PROPEL Contour 
on 1 side (the treatment group) and nothing on the contralateral side (the control group). 
Primary Efficacy 
Endpoint 
Side-to-side difference in FSO patency at Day 45 based on cross-sectional area of FSO by 
CT measurements performed by an independent, blinded reviewer  
Secondary Endpoints 
 
CT grading by an independent, blinded reviewer (Day 45, 180): 
o 
Cross-sectional area of FSO (Day 180 only) 
o 
FSO minimum diameter  
o 
FSOT volume 
o 
Zinreich’s modified Lund-Mackay score for the frontal sinus  
o 
Lund-Mackay score for the frontal sinus 
 
CT grading by clinical investigators (Day 45, 180): 
o 
Lund-Mackay score for the frontal sinus  
 
Endoscopic grading by clinical investigators (Day 21, 45, 90, 180): 
o 
Adhesion/scarring grade in the frontal recess/FSO and ethmoid sinus 
o 
Inflammation score in the frontal recess/FSO 
o 
Polypoid edema in the frontal recess/FSO 
o 
Polyp grade in the ethmoid sinus 
 
Need for post-operative intervention as determined by clinical investigators per 
endoscopy (Day 21, 45, 90, 180) 
 
Patient-reported outcomes: 
o 
CRS side-specific symptom score (Day 21, 45, 90, 180) 
o 
SNOT-22 score (Day 180) 
o 
RSI score (Day 180) 
 
Implant delivery success 
Exploratory Endpoints 
 
Patient satisfaction (Day 90, 180) 
 
Health-economic measures 
Safety Measures 
All adverse events and device deficiencies from enrollment through Day 180 (end of 
study) will be tabulated. 
Study Population 
Patients (≥ 18 years of age) with confirmed diagnosis of CRS who are candidates for in-
office frontal SBD because they present with bilateral stenosis of the FSO and in whom 
placement of PROPEL Contour is feasible and medically appropriate. 
Key Inclusion Criteria 
 
 
Patient is 18 years of age or older. 
 
Patient has confirmed diagnosis of CRS per International Consensus Statement on 
Allergy and Rhinology: Rhinosinusitis 2021 (ICAR:RS) guidelines.  
o 
Patient must have ≥ 12 weeks of ≥ 2 of the following symptoms:  

 
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Clinical Study Protocol P500-1220 (The EXPAND Study) 
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 
nasal obstruction or congestion 
 
nasal discharge (rhinorrhea or post-nasal drip) 
 
facial pain/pressure 
 
reduction/loss of smell 
o 
And ≥ 1 of the following findings: 
 
Evidence of inflammation on paranasal sinus examination or CT; or 
 
Evidence of purulence coming from paranasal sinuses or ostiomeatal 
complex.  
 
In the opinion of the investigator, treatment with the PROPEL Contour Sinus 
Implant as an adjunct to frontal SBD with a 6 mm balloon is technically feasible and 
clinically indicated in FSO. 
 
Female patients of reproductive age and potential must not be pregnant or nursing, 
and patient agrees to avoid becoming pregnant during their participation in the 
study.  
 
Patient has bilateral disease in the frontal sinus (Lund-Mackay score ≥ 1 on each 
side) on CT scan performed within 90 days prior to the baseline. 
 
Confirmation of bilateral FSO access with navigation assistance 
 
A successfully completed in-office bilateral balloon dilation of the FSO with no 
complication on either side that, in the opinion of the investigator is amenable for 
PROPEL Contour Sinus Implant placement in both FSO. 
Key Exclusion Criteria 
 
 
Patient has structural obstruction that precludes endoscopic visualization of one or 
both FSOs prior to implant placement. 
 
Patient had prior Draf III surgery. 
 
Patient had prior sinus surgery or endoscopic sinus surgery (ESS) ≤ 30 days from 
the baseline procedure or the mucosa has not healed yet.  
 
Patient had prior frontal SBD or ESS with corticosteroid containing stents, packing 
materials or implants (e.g., PROPEL, PROPEL Mini, PROPEL Contour) within 
approximately 1 year prior to the baseline procedure.    
 
Patient had prior frontal SBD without corticosteroid containing stents, packing 
materials or implants, or prior balloon dilation in other sinuses with corticosteroid 
containing stents, packing materials or implants, < 30 days from the baseline 
procedure. 
 
Expanded amount of ethmoid sinonasal polyps extending beyond the middle meatus 
(grade > 2) unless reduced 30 days prior to the baseline procedure  
 
Patient has 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 
 
Patient has used parenteral or injected steroids (e.g., Kenalog) within 30 days prior 
to the baseline procedure. 
 
Patient has used oral steroids, budesonide or other sinus steroid irrigations/rinses or 
drops, nebulized steroids administered nasally within 14 days prior to baseline 
procedure. 
Treatment Strategy 
 
 
At the end of a successful in-office bilateral frontal BSD, the left or right FSO is 
randomly assigned to receive 1 PROPEL Contour.  
 
No hemostatic packing materials of any kind are placed within the left or right FSO 
unless medically necessary. 

 
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Clinical Study Protocol P500-1220 (The EXPAND Study) 
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 
Packing such as the Merocel may be placed in the nasal or ethmoid cavity, if 
necessary. No use of steroid soaked packing materials is permitted.   
 
Other than implantation of one PROPEL Contour Sinus Implant on 1 frontal sinus 
side of the patient at the baseline procedure, no steroid-containing intranasal splints, 
spacers or corticosteroid-eluting sinus implants (PROPEL, PROPEL Mini, PROPEL 
Contour, SINUVA) in any sinuses are allowed. 
 
It is preferred that the PROPEL Contour Sinus Implant in the FSO be left in place 
for at least 30 days but can be removed at clinical investigator discretion. 
Prior and Concomitant 
Medications 
 
 
Allowed prior to and post-baseline procedure: 
o 
INCS sprays prior to and post, starting after 7 days 
o 
Orally inhaled steroids for control of asthma 
o 
Stable regimens of leukotriene inhibitors and/or immunotherapy for allergies  
 
Not allowed prior to the baseline procedure: 
o 
A 30-day restriction for use of parenteral and injected steroids (e.g., Kenalog) 
o 
A 14-day restriction for use of oral steroids, budesonide and/or any other sinus 
steroid irrigations/rinses or drops, nebulized steroids administered nasally 
o 
A 45-day restriction for biologics for CRS treatment (such as Dupixent) 
 
Allowed post-baseline procedure: 
o 
Daily use of saline sprays/rinses/irrigations in both sinuses starting on Day 1 
o 
Antibiotics if infection is suspected  
o 
INCS sprays (excluding Xhance) in one or both sinuses starting after 7 days as 
clinically necessary. 
 
Not allowed post-baseline procedure:  
o 
Other corticosteroids (e.g., oral, parenteral, injections, budesonide or other 
sinus steroid irrigations/rinses or drops, breath powered Xhance, nebulized 
steroids administered nasally or other drug eluting stents) through Day 45, 
unless clinically necessary, to ensure unbiased assessment of the primary 
endpoint  
o 
Biologics for CRS (such as Dupixent) 
Subject Follow-Up 
Subjects are required to complete 4 follow-up visits at Day 21, 45, 90 and 180 (end of 
study). 
Note: Day 45 CT should be obtained after suctioning and clearing mucous of the FSO and 
any implant debris to prevent unblinding. Investigators will confirm that no implant 
remnants are visible on the Day 45 CT scan before submitting it for blinded review. 
Duration of Study 
For a given subject: approximately 182 days = screening visit (1 day) + 
baseline/procedure (1 day) + follow-up (180 days). 
Overall: Approximately 15 months = 9-month enrollment phase + 6-month follow-up. 

 
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6 
STUDY FLOW DIAGRAM 
Randomize
N = 80
Consent/Screening
Study Population
CRS patients (≥ 18 yr) with bilateral frontal sinus 
disease confirmed by stenosis on endoscopy and 
LM score ≥1 on each side by CT scan who are 
candidates for in-office SBD
Medications
Day 21
(± 7 d)
Day 45
(± 7 d)
In-office bilateral frontal SBD  
Treatment 
n = 80 sinuses
ENT
Endoscopic 
evaluation & video 
recording
Endoscopic 
evaluation & video 
recording
Bilateral frontal 
BSD
Randomization
Implant placement 
Implant apposition 
evaluation
Control
n = 80 sinuses
CT Scan
(≤ 90 days prior 
to baseline)
CT Scan 
(Primary efficacy 
endpoint)
CT Scan
Day 180
(end of study)
(± 14 d)
CT Scan
No parental or injected steroids 
for ≤ 30 days
 
No oral steroids, budesonide or 
other steroid irrigations/rinses/
drops, nebulized steroids ≤ 14 
days
INCS sprays allowed up 
to baseline procedure.
Day 90
(± 14 d)
Endoscopic 
evaluation & video 
recording
Endoscopic 
evaluation & video 
recording
Subject
Eligible?
Screen fail
Baseline assessments 
Yes
No
Endoscopic 
evaluation & video 
recording
SNOT-22, RSI, CRS side-
specific symptom 
questionnaires
CRS side-specific 
symptom 
questionnaires
SNOT-22, RSI, CRS side-
specific symptom 
questionnaires
Baseline/Procedure
Daily saline irrigation 
recommended starting Day 1
INCS sprays starting Day 7, if 
clinically necessary
Maintenance therapy for asthma 
and allergies  allowed, if clinically 
necessary  
Antibiotics, if clinically necessary
Other corticosteroids prohibited 
through Day 45, unless clinically 
necessary 
Endoscopic 
evaluation & video 
recording
CRS side-specific 
symptom 
questionnaire
CRS side-specific 
symptom 
questionnaire
 
Abbreviations: CRS, chronic rhinosinusitis; CT, computed tomography; d, day; FSO, frontal sinus ostia/ostium; LM, Lund-
Mackay; RSI, Rhinosinusitis Symptom Inventory; SBD, sinus balloon dilation; SNOT, Sino-Nasal Outcome Test. 

 
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Clinical Study Protocol P500-1220 (The EXPAND Study) 
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7 
SCHEDULE OF ASSESSMENTS 
Assessments 
Screening 
Baseline/ 
Procedure 
(≤ 30 d from 
consent date) 
Day 21 
 
 
(± 7 d) 
Day 45 
(primary 
endpoint) 
(± 7 d) 
Day 90 
 
 
(± 14 d) 
Day 180 
(end of 
study) 
(± 14 d) 
Informed consent 
X 
 
 
 
 
 
Medical/surgical history 
X 
 
 
 
 
 
CT scan1 
X 
 
 
X 
 
X 
Endoscopic evaluation & video recording 
X2 
X2 
X 
X 
X 
X 
SNOT-22 questionnaire 
 
X3 
 
 
 
X 
RSI questionnaire 
 
X3 
 
 
 
X 
CRS side-specific symptom questionnaire 
 
X3 
X 
X 
X 
X 
In-office bilateral frontal SBD 
 
X 
 
 
 
 
Randomization 
 
X 
 
 
 
 
PROPEL Contour placement in FSO4 
 
X 
 
 
 
 
Patient satisfaction questionnaire 
 
 
 
 
X 
X 
Adverse event reporting 
X 
X 
X 
X 
X 
X 
Device deficiency reporting 
 
X 
X 
X 
X 
X 
Concomitant medications 
X 
X 
X 
X 
X 
X 
Abbreviations: CT, computed tomography; d, day; FSO, frontal sinus ostia/ostium; RSI, Rhinosinusitis Symptom Inventory; SBD, 
sinus balloon dilation; SNOT, Sino-Nasal Outcome Test. 
1  Screening CT must be performed ≤ 90 days prior to the baseline procedure to confirm the diagnosis of CRS. The follow-up CT at 
Day 45 and 180 shall be performed after endoscopic evaluation and debridement to ensure no implant remnants are present on the 
scan. All CTs should be uploaded for centralized blinded review. 
2  Screening endoscopic evaluation can be done at the baseline. Baseline values are entered into EDC. 
3  Complete endoscopic evaluation, SNOT-22, RSI and CRS side-specific symptom questionnaires prior to the baseline procedure. 
Assess implant apposition after the baseline procedure. 
4  Treatment side only. 
 
 

 
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8 
BACKGROUND INFORMATION 
8.1 
Literature Review 
Endoscopic sinus surgery (ESS) is recommended for patients with chronic rhinosinusitis (CRS) 
who have failed appropriate medical therapy (Orlandi 2021). While ESS has been demonstrated 
to be effective in reducing patient-reported symptoms in the short term, longer-term success rates 
have been reported in the range of 76% to 98% (Naidoo 2012, Ramadan 1999). Meanwhile, a 
relatively large number of patients continue to be symptomatic or experience recurrent symptoms 
or revision surgery within 1-2 years. Causes of surgical failure are numerous and include 
lateralization of the middle turbinate, adhesion formation between the middle turbinate and lateral 
nasal wall, ostial stenosis, persisting or recurrent mucosal edema, and polyposis. The same post-
operative failure mechanisms within the ethmoid sinus apply to the frontal recess and frontal sinus 
ostia. These include formation of scarring, adhesions, synechiae, recurrent inflammation, and 
polyposis (Chandra 2004). 
Many surgeons consider the postoperative treatment regimen to be as important as the surgery 
itself (Bugten 2006). There is strong evidence that postoperative endoscopic examination of the 
sinonasal cavity provides prognostic information concerning the potential for future episodes of 
sinusitis and that patients whose cavities became normal post-operatively are less likely to require 
revision (Kennedy 2000). Meticulous post-operative care following ESS involves several follow-
up visits over the ensuing months. Maintenance of the surgical result is accomplished by routine 
endoscopic examination, meticulous cleaning of the cavity using saline rinses, debridement or 
other manipulations to remove adhesions, and adjustments in pharmacotherapy. Formation of 
adhesions, scarring, synechiae, middle turbinate lateralization, ostial stenosis and edema are major 
concerns often addressed by use of sinus stents and injectable gels. To address these post-operative 
issues, Intersect ENT (Menlo Park, CA) developed the PROPEL, PROPEL Mini and PROPEL 
Contour Sinus Implants.  
The PROPEL Contour Sinus Implant was approved on 23 February 2017 for placement in 
maxillary and frontal sinuses following sinus surgery in CRS patients to maintain patency of the 
sinus ostia. Positive data from the PROPEL Contour Sinus Implant cohort of the PROGRESS 
study, a prospective, randomized, blinded, multi-center trial of 80 patients designed to assess the 
safety and efficacy of the implant when placed in the frontal sinuses following surgery (Luong 
2018, Singh 2019), and a non-randomized, open-label EXCEED study in 15 patients for frontal 
and maxillary ostia, supported the approval. The study met its primary efficacy endpoint, 
demonstrating a statistically significant 65% relative reduction in the need for post-operative 
interventions, such as the need for additional surgical procedures or the need for oral steroid 
prescription, compared to surgery alone. The study utilized an intra-patient control design to assess 
the safety and efficacy of the PROPEL Contour Sinus Implant when placed following surgery 
performed in operating room on one sinus side compared to surgery alone on the contralateral side. 
The study results showed that placement of the PROPEL Contour Sinus Implant in the FSO 

 
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maintained sinus patency by reducing inflammation, scarring and polypoid edema. The study also 
confirmed that implant placement in the FSO poses negligible safety risks.  
8.2 
PROPEL Contour Sinus Implant 
8.2.1 
Description 
A summary description of the PROPEL Contour Sinus Implant (Figure 1) is provided below.  For 
more detailed delivery system and implant information, refer to the Instructions for Use (IFU). 
The PROPEL Contour Sinus Implant (part # 70033) is designed to accommodate the size and 
variability of the human sinus anatomy. The implant is intended to be inserted by a physician under 
endoscopic visualization and once positioned, is designed to be self-retaining against the mucosal 
surface in the area of the frontal recess/FSO. 
The PROPEL Contour Sinus Implant is fabricated from a bioabsorbable monofilament polymer 
material commonly used in a variety of medical products, including dissolvable sutures. The 
implant is designed with an hour-glass shape to aid in anchoring / apposition to the tissue with the 
following dimensions: waist diameter = 15.5 mm (nominal), outer diameter = 27.0 mm (nominal), 
and height = 8.0 mm (nominal).  
 
Figure 1: PROPEL Contour Sinus Implant 
 
8.2.2 
Intended Use 
The PROPEL Contour Sinus Implant is intended for use in patients ≥ 18 years of age to maintain 
patency of the frontal and maxillary sinus ostia following sinus surgery and locally deliver steroids 
to the sinus mucosa. The PROPEL Contour Sinus Implant separates/dilates mucosal tissues 
prevents obstruction by adhesions/scarring and reduces edema. The implant reduces the need for 
post-operative intervention such as surgical adhesion lysis and/or use of oral steroids. 
 
9 
STUDY OBJECTIVE AND ENDPOINTS 
The objective of the EXPAND study is to evaluate the efficacy of PROPEL Contour placement in 
the FSO following in-office bilateral frontal SBD in patients with CRS. 

 
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9.1 
Primary Efficacy Endpoint  
Side-to-side difference in FSO patency at Day 45 based on cross-sectional area of FSO using CT 
measurements performed by an independent, blinded reviewer. 
9.2 
Secondary Endpoints 
 
CT grading by an independent, blinded reviewer (Day 45, 180): 
o 
Cross-sectional area of FSO (Day 180 only) 
o 
FSO minimum diameter 
o 
FSOT volume 
o 
Zinreich’s modified Lund-Mackay score for the frontal sinus 
o 
Lund-Mackay score for the frontal sinus 
 
CT grading by clinical investigators (Day 45, 180): 
o 
Lund-Mackay score for the frontal sinus 
 
Need for post-operative intervention as determined by clinical investigators based on 
endoscopic evaluation (Day 21, 45, 90, 180): 
o 
Repeat frontal SBD warranted or performed for restenosis/occlusion in the frontal 
recess/FSO; or 
o 
Surgical intervention warranted or performed to debride obstructive 
adhesions/scarring or for restenosis/occlusion in the frontal recess/FSO; or 
o 
Oral steroids warranted or prescribed to resolve recurrent edema in the frontal 
recess/FSO 
 
Endoscopic grading by clinical investigators (Day 21, 45, 90, 180): 
o 
Adhesion/scarring grade in the frontal recess/FSO and ethmoid sinus 
o 
Inflammation score in the frontal recess/FSO 
o 
Polypoid edema in the frontal recess/FSO 
o 
Polyp grade in the ethmoid sinus 
 
Patient-reported outcomes: 
o 
CRS side-specific symptom score (Day 21, 45, 90, 180) 
o 
SNOT-22 score (Day 180) 
o 
RSI score (Day 180) 
 
Implant delivery success rate by clinical investigators 

 
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9.3 
Exploratory Endpoints 
 
Patient satisfaction (Day 90, 180) 
 
Health-economic measures to determine health-care resource utilization (see Section 9.5) 
9.4 
Safety Measures 
All adverse events (AEs) for each subject from the time the subject gives informed consent through 
Day 180 will be recorded in the electronic data capture (EDC) system and monitored.  Each AE 
will be evaluated by the clinical investigators for their seriousness and relationship to the study 
devices. Where possible and if applicable, AEs will be localized to a sinus location. 
Safety will be determined by assessment of, adverse device effects (ADE), serious adverse events 
(SAEs), unanticipated adverse device effect (UADE) and unanticipated serious adverse device 
effect (USADE) from enrollment through Day 180 post-procedure (Section 4). All events will be 
separated between those attributed to PROPEL Contour Sinus Implant, those attributed to Cube 
Navigation System, VenSure™ Nav Balloon Device, Inflation device, Balloon Dilation Procedure, 
Implant Placement Procedure, and those that are a mix or indistinguishable. 
9.5 
Health-Economic Measures 
Usage of the following interventions will be tracked and the first occurrence of each will be 
reported through Day 180: 
 
Treatment with antibiotics 
 
Use of intranasal corticosteroid (INCS) sprays starting after Day 7  
 
Use of other corticosteroids (e.g., oral, parenteral, injections, budesonide or other sinus 
steroid irrigations/rinses or drops, breath powered steroid delivery [e.g. XHANCE™, 
fluticasone proprionate], nebulized steroids administered nasally, or other drug eluting 
stents)  
 
Regimens of leukotriene inhibitors and/or immunotherapy for allergies  
 
Post-operative surgical interventions: 
o 
Post-operative debridement will be tracked separately but is within the expected post 
dilation outcome. 
o 
Use of post-operative intervention is a composite endpoint that includes:  
i. 
Device procedure reintervention including repeat balloon dilation or repeat 
implant placement will be tracked, and /or 
ii. 
Oral steroid intervention warranted to resolve recurrent inflammation or edema 
in the frontal recess/FSO.  The sinus type (frontal) and side warranting surgical 
intervention is noted on the endoscopic assessment CRF. 

 
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 
Hospitalizations 
 
ENT-related office visits 
10 
STUDY DESIGN  
This is a post-market, randomized, intra-patient controlled, blinded, multicenter trial enrolling 80 
randomized subjects from up to 20 US sites. No single site should enroll more than 16 subjects 
(20% of the total enrollment) for this study. Study subjects will be randomized following a 
successful in-office bilateral frontal BSD to receive one PROPEL Contour Sinus Implant on one 
FSO side (treatment), while the contralateral side serves as a control (see Section 6). Subjects are 
expected to return for 4 follow-up visits at Day 21, 45, 90 and 180 (end of study). Endoscopic 
evaluation will be conducted at each visit, and CT scan will be repeated at Day 45 and 180 (see 
Section 7). 
11 
STUDY POPULATION 
Patients (≥ 18 years of age) with confirmed diagnosis of CRS who are candidates for in-office 
frontal SBD because they present with bilateral stenosis of the FSO and in whom placement of the 
PROPEL Contour is feasible and medically appropriate as determined by clinical investigator. 
11.1 
Inclusion Criteria 
Subjects are eligible for the study if they meet all the following criteria: 
General inclusion criteria 
a. Patient has provided written informed consent using a form approved by the reviewing IRB. 
b. Patient is 18 years of age or older. 
c. Patient is willing and able to comply with protocol requirements. 
d. Patient has confirmed diagnosis of CRS per International Consensus Statement on Allergy and 
Rhinology: Rhinosinusitis 2021 (ICAR:RS) guidelines.  
Patient must have ≥ 12 weeks of: 
Two or more of the following symptoms:  
 nasal obstruction or congestion 
 nasal discharge (rhinorrhea or post-nasal drip) 
 facial pain/pressure 
 reduction/loss of smell 
 
And one or more of the following findings: 
 
Evidence of inflammation on paranasal sinus examination or CT  

 
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 Evidence of purulence coming from paranasal sinuses or ostiomeatal complex 
e. In the opinion of the investigator, treatment with the PROPEL Contour Sinus Implant as an 
adjunct to frontal BSD with a 6 mm balloon is technically feasible and clinically indicated in 
both FSO. 
f. Female patients of reproductive age and potential must not be pregnant or nursing, and patient 
agrees to avoid becoming pregnant during their participation in the study.  
CT Imaging inclusion criteria 
g. Patient has bilateral disease in the frontal sinus (Lund-Mackay score ≥1 on each side) on CT 
scan performed ≤ 90 days prior to the baseline procedure. 
Intraprocedural inclusion criteria 
h. Patient is able to tolerate topical/local anesthesia. 
i. Confirmation of bilateral FSO access with navigation assistance 
j. A successfully completed in-office bilateral balloon dilation of the FSO with no complication 
on either side that, in the opinion of the investigator is amenable for PROPEL Contour Sinus 
Implant placement in both FSO. 
11.2 
Exclusion Criteria 
Subjects are eligible for the study if they meet none of the following criteria: 
General exclusion criteria 
a. Patient has structural obstruction that precludes endoscopic visualization of one or both FSOs 
prior to implant placement. 
b. Patient had prior Draf III surgery. 
c. Patient had prior sinus surgery or ESS ≤ 30 days from the baseline procedure or the mucosa 
has not healed from prior sinus surgery or ESS.  
d. Patient had prior frontal SBD or ESS with corticosteroid containing stents, packing materials 
or implants (e.g., PROPEL, PROPEL Mini or PROPEL Contour) within approximately 1 year 
prior to the baseline procedure.  
e. Patient had prior frontal SBD without corticosteroid containing stents, packing materials or 
implants, or prior balloon dilation in other sinuses with corticosteroid containing stents, 
packing materials or implants, ≤ 30 days prior to the baseline procedure. 
f. Expanded amount of ethmoid sinonasal polyps extending beyond the middle meatus (grade > 
2) unless reduced ≥ 30 days prior to the baseline procedure. 
g. Patient has oral-steroid dependent condition such as chronic obstructive pulmonary disease 
(COPD) or other conditions. 

 
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h. Known history of allergy or intolerance to corticosteroids or mometasone furoate. 
i. Patients with a known hypersensitivity to lactide, glycolide or caprolactone copolymers.  
j. Patients with electronic devices in direct connection to the brain or the nervous system such as 
implantable neurostimulators (e.g., deep brain stimulation), programmable CSF shunts. 
k. Patients with monopolar pacemakers (older designs, with lower resistance to interference) or 
ICD’s (implantable cardioverter defibrillator). 
l. Patients with implantable, body worn devices such as insulin pumps. 
m. Patient has clinical evidence of acute bacterial sinusitis (e.g., acute increase of purulent 
discharge, fever). 
n. Patient has clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on CT 
scan, necrotic sinus tissue). 
o. Patient has an active viral illness (e.g., COVID-19, flu, shingles). 
p. Patient has active bacterial infection other than in the sinuses requiring oral antibiotics, unless 
resolved prior to baseline procedure. 
q. Patient has clinical evidence of disease or condition that is likely to compromise survival or 
ability to complete follow-up assessments through Day 180 (end of study). 
r. Patient has used parenteral or injected steroids (e.g., Kenalog) ≤ 30 days prior to the baseline 
procedure. 
s. Patient has used oral steroids, budesonide or other sinus steroid irrigations/rinses or drops, 
nebulized steroids administered nasally ≤ 14 days prior to the baseline procedure. 
t. Patient is currently participating in another clinical trial. 
Intraprocedural exclusion criteria:  
u. Patient fails the field mapping check during the pre-baseline procedure navigation assessment.  
v. Other than implantation of one PROPEL Contour on one frontal sinus side of the subject at the 
baseline procedure, use of corticosteroid-eluting sinus implants (PROPEL, PROPEL Mini, 
PROPEL Contour, SINUVA®) or other steroid soaked packing materials in any sinuses. 
11.3 
Subject Withdrawal 
Study subject may be withdrawn or terminated for the following reasons: 
 
Subject death 
 
Concomitant disease or any pre-existing disease or condition that precludes subject’s 
participation 
 
Subject voluntarily chooses not to participate further in the study. 

 
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 
Subject’s non-compliance with study procedures 
 
Lost to follow-up: the subject has missed a study visit and three documented attempts to 
contact the subject are unsuccessful. A subject who misses a study visit should be contacted 
by site personnel to determine the reason for the missed visit, which should be documented 
in the subject’s study records. Note: A subject who misses a study visit but attends a 
subsequent visit will no longer be considered lost to follow-up, and their previous missed 
visits will become ‘missed visits’. 
 
In the clinical investigator’s opinion, a significant safety concern arises that requires subject 
discontinuation. 
 
In the clinical investigator’s opinion, it is not in the best interest of the subject to continue 
study participation. 
 
In the sponsor’s or IRB’s opinion, it is not in the best interest of subject to continue the study. 
If a subject decides to withdraw from the study, clinical investigator should follow patients with 
ongoing AEs till resolution according to the standard of care. Data collected up to the point of 
subject withdrawal or termination will be maintained in the study database and included in 
analyses as appropriate. All enrolled subjects, including those withdrawn or lost to follow-up, will 
be accounted for and documented. 
12 
SUBJECT TREATMENT AND STUDY PROCEDURES 
12.1 
Pre-screening 
During the pre-screening phase, the investigator or designee performs an initial evaluation of 
potential candidates for study eligibility. This initial pre-screening phase may include review of 
existing patient information (e.g., CT scans, previously performed diagnostic measures, laboratory 
studies, medical history, physical examination).   
12.2 
Informed Consent, Enrollment and Screening 
If the patient appears to be a potential candidate for the study based on existing information, written 
informed consent will be obtained. No protocol required testing will be performed solely for the 
purposes of this study prior to obtaining written informed consent. 
Clinical investigators or designees will approach the patient to obtain written informed consent. 
The background of the proposed study, the dilation procedure, implantation, the follow-up 
schedule and all potential risks and benefits will be carefully explained to each patient. The clinical 
investigator or designee obtaining the informed consent shall be in compliance with ICF 
regulations: 
Each patient must sign and date the ICF approved by an appropriate Institutional Review Board 
(IRB). Patients are considered enrolled in the study upon signing the IRB-approved ICF. Enrolled 

 
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subjects will be assigned unique identifying codes by the Electronic Data Capture (EDC) system 
and entered into the study database. Upon enrollment, subjects will have a screening assessment. 
The screening assessment will include: 
 
Review of CT scan (must be performed ≤ 90 days prior to baseline procedure; see Section 
13) 
 
Endoscopic evaluation with grading and video recording; and 
 
Female subjects of childbearing potential must confirm their nursing status, undergo 
pregnancy test to confirm they are not pregnant.  
If the screening visit occurs on the same day as the baseline/procedure visit, all assessments will 
be recorded in the baseline visit forms (see Section 7). All subjects who do not pass the screening 
assessment, including successfully completed in-office bilateral balloon dilation of the FSO with 
no complication and amenable for PROPEL Contour placement will be considered as screen 
failures and will be terminated from the study. The reason for ineligibility will be recorded in the 
EDC system. 
12.3 
Baseline/Procedure 
Subjects should undergo the baseline procedure within approximately 30 days from signing the 
ICF. Final eligibility requirements will be assessed at the baseline visit. Subjects will undergo a 
baseline endoscopic examination, including grading prior to any surgical procedure(s). Video 
endoscopy capture is required, pictures are optional. Subjects will also undergo baseline 
assessments such as SNOT-22, RSI, and CRS side-specific symptom questionnaires before any 
surgical procedures. 
 
Female subjects of childbearing potential will need to confirm not pregnant or nursing prior 
to the baseline procedure per site standards.  
 
Subject preparation for baseline procedure 
 
Subjects will be prepared for the baseline procedure per standard investigator protocol used 
for nasal endoscopy and procedures.  
 
The anesthesia period should be as long as necessary to ensure complete numbness of the 
subject’s septum and middle turbinate. Once properly anesthetized, subjects will undergo the 
baseline procedure. 
12.3.1 
Bilateral Frontal SBD 
Confirm bilateral FSO access and complete bilateral in-office dilation per the Cube Navigation 
System, VenSure™ Nav Balloon Device, and Inflation Device IFUs.  If the eligibility CT Scan 
does not meet the Cube Navigation System requirements, the CT Scan may need to be re-done. 

 
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Subjects may be asked to take off their mask (just like earrings, glasses, etc.,) for the few seconds 
during which the CT scan is captured to maximize accuracy with the navigation system. 
Prior to implant placement: 
● Confirm successful bilateral frontal SBD with an opening amendable for PROPEL Contour 
placement on each side.  
● Evaluate final subject eligibility by confirming that the subject’s anatomy and overall condition 
is appropriate for PROPEL Contour placement. 
12.3.2 
Optional In-office Procedures 
If clinically necessary, in-office sinus surgical procedures (e.g., inferior turbinate reduction, 
concha bullosa treatment) may be performed according to standard of care at the baseline visit 
prior to randomization. Traditional surgical septoplasty for inferior septal deviation such as bone 
spur on maxillary crest may be performed.  Packing such as Merocel may be placed in the nasal 
or ethmoid cavity, if necessary.  These procedures should be performed bilaterally on each side of 
the sinuses.   
If clinically necessary, bilateral dilation of the maxillary or sphenoid sinuses may be performed 
using the study devices (i.e., Cube Navigation System, VenSure Nav Balloon Device) after 
completing bilateral frontal BSD of the FSO. Alternatively, the investigator may use a 
commercially available balloon dilation device to dilate the maxillary, sphenoid sinuses or 
eustachian tubes.   
Septoplasty ballooning and ethmoidectomy (anterior, posterior, total) are not permitted at the 
baseline visit prior to randomization. Polypectomy of nasal polyps extending beyond the middle 
meatus (grade >2) is not permitted. Draf I, Draf II a/b, Draf III or any other procedures involving 
cutting to the frontal sinuses are not permitted. No use of steroid soaked packing materials is 
permitted.  
12.3.3 
Randomization 
Subjects meeting final eligibility and undergoing the successful completion of bilateral frontal 
BSD will be randomized using the envelop method to receive 1 PROPEL Contour on the treatment 
side. 
12.3.4 
Implant Placement 
PROPEL Contour is provided by sponsor and must be placed by trained PIs according to the IFU. 
No hemostatic packing materials of any kind should be placed within the implants unless medically 
necessary. Packing such as the Merocel tampon may be placed in the nasal or ethmoid cavity, if 
necessary. No other packing materials or interventions containing steroids of any kind should be 
placed in any other sinus.   

 
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● Record video and perform endoscopy of post-procedure anatomy, including adequate view of 
the frontal sinus recess implant deployment and final implant placement; and 
● Record the implant apposition on the CRF. 
The study treatment phase begins upon introduction of the PROPEL Contour Sinus Implant 
delivery system into the study subject after successful bilateral balloon dilation of the FSO.  
The PROPEL Contour Sinus Implant delivery system should be disposed per standard institutional 
practices for biohazard waste.   
If the sinus implant, implant delivery system, VenSure Nav Balloon Device, Inflation Device, or 
other components are associated with a device-related AE, deficiency, malfunction or failure, the 
impacted device or its parts should be returned to sponsor for evaluation, if possible. For the return 
of biohazard product, sponsor must be contacted prior to product return for handling instructions. 
12.4 
Follow-Up  
The follow-up period begins immediately post-treatment (once the study implant is placed in the 
subject in the clinical investigator’s office).  
At each follow-up visit, the subject will undergo endoscopic evaluation with grading and video 
recording at Day 21, 45, 90 and 180 (end of study). After suctioning, endoscopic grading is 
performed and recorded on the endoscopic assessment CRFs. Suctioning and clearing 
mucous/stent debris of the FSO should be completed prior to Day 45 CT scan. It is preferred that 
the PROPEL Contour Sinus Implant be left in place for 30 days but can be removed at investigator 
discretion.   
An overview of the assessments to be performed at each follow-up interval along with required 
timing is provided in Section 7.  
A CT scan is repeated at Day 45 (primary endpoint) and again at Day 180. The acquisition and 
measurements by the centralized imaging core lab are detailed in Section 13.  
12.5 
Unscheduled Visits  
Subjects may come in for additional unscheduled office visits if necessary. Circumstances that 
may warrant additional visits include but are not limited to:  
 
Worsening of sinus symptoms, and/or 
 
Sinus-related adverse events requiring medical evaluation. 
The assessment at an unscheduled visit may consist of: 
 
Endoscopic evaluation with grading and video recording; and. 
 
SNOT-22, RSI and site-specific symptom questionnaires. 

 
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13 
CT SCAN AND PRODUCT ACCOUNTABILITY 
13.1 
Image Acquisition 
The screening CT scan must be performed ≤ 90 days prior to the baseline procedure to confirm the 
diagnosis of CRS after a period of appropriate medical therapy and prior to making a 
recommendation for BSD. The follow-up CT at Day 45 and 180 shall be performed after 
endoscopic evaluation and debridement to ensure no implant remnants are present on the scan to 
ensure blinded review. 
The subject needs to be in seated position with the chin in a chin rest for imaging to occur. The 
cone-beam CT scan window must encompass the frontal, ethmoid, maxillary and sphenoid sinuses 
and OMC on both sides in the axial, coronal and sagittal planes.  
13.2 
Centralized Blinded Review 
The primary efficacy endpoint requires precise measurements of the FSO using reconstructed cone 
beam images in the axial, coronal and sagittal planes. The image reconstructions and 
measurements of CT-related endpoints will be performed by board-certified independent 
radiologists at the centralized imaging core lab in accordance with the standardized protocol (see 
CP-00038). The reviewers will be blinded to treatment assignment and have no access to any 
symptomatic or endoscopic outcomes. 
13.3 
Product Accountability 
An appropriate number of EXPAND study devices including Inflation Device will be provided to 
the study sites. The sites maintain the EXPAND study devices in a locked, secure location. Only 
clinical investigators participating in the study will have access to the EXPAND study devices. 
Dispensing of EXPAND study devices will be documented by authorized personnel. Each batch 
of the PROPEL Contour Sinus Implant, VenSure Nav Balloon Device and Inflation Device will 
be tracked by the unique device identifier. 
EXPAND study devices including the unique device identifier received by the clinical site will be 
logged in by the site personnel on inventory logs and/or the EDC system. Final reconciliation will 
be completed at each site before or during site closure. Any unused inventory and Cube Navigation 
System will be returned to the sponsor at the direction of the sponsor or at the close of the study. 
At the end of the study, overall study final device reconciliation will be completed internally by 
the sponsor. 
14 
PRIOR AND CONCOMITANT MEDICATIONS 
The following medication is allowed prior to and post-baseline procedure: 
 
INCS sprays prior to and post, starting after 7 days 
 
Orally inhaled steroids for control of asthma; and 

 
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 
Stable regimens of leukotriene inhibitors and/or immunotherapy for allergies 
The following medication is not allowed prior to the baseline procedure: 
 
A 30-day restriction for use of parenteral and injected steroids (e.g., Kenalog) 
 
A 14-day restriction for use of oral steroids, budesonide and/or any other sinus steroid 
irrigations/rinses or drops, nebulized steroids administered nasally; and  
 
A 45-day restriction for biologics for CRS treatment (such as Dupixent). 
The following medication is allowed post-baseline procedure: 
 
Daily use of saline sprays/rinses/irrigations in both sinuses from Day 1 
 
Antibiotics if infection is suspected at any time during the study; and 
 
INCS sprays (excluding Xhance) in one or both sinuses starting after 7 days as clinically 
necessary. 
The following medication not allowed post-baseline procedure:  
 
Other corticosteroids (e.g., oral, parenteral, injections, budesonide or other sinus steroid 
irrigations/rinses or drops, breath powered Xhance, nebulized steroids administered nasally 
or other drug eluting stents) through Day 45, unless clinically necessary, to ensure unbiased 
assessment of the primary endpoint; and 
 
Biologics for CRS treatment (e.g., Dupixent). 
15 
MEDICAL AND SURGICAL INTERVENTIONS 
Subsections below describe the rescue treatments consisting of medical and surgical interventions 
that will be allowed during the study follow-up based upon subject’s symptomatic and endoscopic 
outcomes. 
15.1 
Medical Intervention 
During study follow-up, INCS sprays (excluding Xhance) will be allowed starting after Day 7 
visit, if clinically necessary.  
Other corticosteroids (e.g., oral, parenteral, injections, budesonide or other sinus steroid 
irrigations/rinses or drops, breath powered Xhance, nebulized steroids administered nasally or 
other drug eluting stents) are not allowed through Day 45, unless there is a clinically significant 
increase or persistence in frontal sinus inflammation, coupled with subject complaint of sinusitis 
symptoms that cause subject to request medical intervention. 
15.2 
Surgical Intervention 
Surgical intervention (e.g., repeat balloon dilation or sinus surgery, in-office polypectomy) may 
be required in cases where a clinically significant increase or persistence in frontal sinus 

 
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inflammation occurs, coupled with complaints of sinusitis symptoms that cause subject to prefer a 
surgical intervention (e.g., sinus surgery). 
All medical and surgical interventions will be noted on the concomitant medication and follow up 
CRFs. 
16 
ASSESSMENT OF SAFETY 
16.1 
Specification of Safety Parameters 
Adverse events (AE) for each subject from the time the subject gives written informed consent 
(enrollment) through Day 180 (end of study) will be recorded in the EDC system and monitored. 
Each AE will be evaluated by clinical investigators in terms of severity (i.e., mild, moderate, 
severe) as well as strength of relationship (i.e., not related, unlikely related, probably related, 
definitely related, indeterminate) to the study drug (mometasone furoate), study devices, and 
procedures (BSD, implant placement). Each AE will be reviewed by sponsor in accordance with 
sponsor’s SOP. The study sponsor is responsible for ensuring that all AEs are appropriately 
recorded, adjudicated and, when applicable, reported to the government(s), ethics committee(s) 
and other study centers per applicable regulations. 
Subjects with CRS experience a persisting set of symptoms associated with the disease and may 
continue to present with a wide range of symptoms during the recovery process after in-office 
balloon dilation. These may include symptoms such as pain and discomfort, headache, decreased 
sense of smell, crusting, epistaxis, and other symptoms. Patients healing appropriately after in-
office procedure may suffer from acute infections and/or inflammatory exacerbations unrelated to 
the procedure due to the natural course of their CRS. Therefore, clinical investigators will evaluate 
the occurrence of AEs excluding usual post-operative recovery signs and symptoms experienced 
by study subjects, unless corroborated by objective findings and/or requiring specific medical or 
therapeutic interventions (e.g., antibiotics, repeat ESS). 
Note: The need for medical or surgical intervention in the FSO post-dilation that is captured on 
the endoscopic assessment CRF will not be considered as an AE. Likewise, other endoscopic 
findings such as inflammation, adhesion/scarring, and edema of the FSO will not be considered as 
AEs. 
16.2 
Classification of AEs 
16.2.1 
AE severity 
Each AE will be categorized in terms of their severity as defined in table below. 

 
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16.2.2 
AE causality 
The relationship of each AE to the study drug (i.e., mometasone furoate), study devices (i.e., 
PROPEL® Contour Sinus Implant, VenSure™ Nav Balloon Device, Cube Navigation System), 
and procedures (i.e., frontal BSD, implant placement) will be evaluated by PIs and categorized as 
defined in table below. 
 
Any AE that is determined by a participating investigator to be related (definitely or probably 
related) to the study drug, study device, or procedure will be categorized as device related. All AEs 
will be attributed separately to each device (i.e., PROPEL Contour Sinus Implant, VenSure™ Nav 
Balloon Device, Cube Navigation System), each study procedure (i.e., inflation device, BSD, 
implant placement), and any other in-office baseline procedures, as well as those that are a mix or 
indistinguishable. 
For device-related AE (anticipated or unexpected/unanticipated), the sponsor may request source 
documentation to confirm the relationship of the AE to the study devices and may review such AE 
with an independent otolaryngologist, as needed.  
16.2.3 
AE expectedness 
It is sponsor’s responsibility to evaluate expectedness of each device-related AE in accordance 
with sponsor’s SOP. Expectedness is categorized as defined in table below. 
Severity 
Definition 
Mild 
Events, signs or symptoms that are easily tolerated by the subject, or are clinical or 
diagnostic observations of the investigator 
Moderate 
Events, signs or symptoms that cause discomfort and interfere with normal functioning. 
Local or noninvasive intervention may be indicated 
Severe 
Events, signs or symptoms that disable the subject, are medically significant, lead to 
hospitalization or prolongation of hospitalization 
Strength of 
Relationship 
Definition 
Definitely 
Clear-cut temporal association, and no other possible cause 
Probably 
Clear-cut temporal association, and a potential alternative etiology are not apparent 
Unlikely 
Does not follow a reasonable temporal association; or causal relationship with the drug, 
devices or procedures involved in the research is unlikely but cannot be completely ruled 
out 
Not-related 
AE is completely independent of study product administration; and/or evidence exists 
that the event is definitely related to another etiology 
Indeterminate 
Information gathered about the AE is not sufficient to arrive at a definite 
conclusion about causal relationship 

 
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16.3 
AE Adjudication 
AEs are reviewed by sponsor on a regular, ongoing basis in accordance with the sponsor’s SOP. 
The following is reviewed for each AE: 
 
Need for clarification or additional information from the site 
 
Appropriateness of classifications for severity, causality and expectedness 
 
If the AE is unanticipated, determination as to whether it poses unreasonable risk of harm to 
study subjects if it were to reoccur; and 
 
Requirements for reporting to the FDA and site IRB based on the nature of the event. 
Outputs of reviews are filed by sponsor, and action items are tracked to resolution. If the 
investigator and sponsor do not agree on the seriousness or causality of an event, the event will be 
reviewed by an independent adjudicator, who is a qualified medical expert. The adjudicator is 
blinded to treatment assignment and will have access to the following: 
 
AE information reported in the EDC system 
 
A list of potential risks associated 
 
Information provided by investigators, including clinical notes, laboratory results, 
concomitant medications, and medical/surgical history; and 
 
Clinical outcome measures reported in the EDC system. 
The independent adjudicator may request further information if this is required to complete AE 
review. The adjudicator will confirm their determination of seriousness and causality of the event. 
The adjudicator’s decision is considered as final and is recorded in the EDC system and used in 
all analyses. 
16.4 
Guidelines for AE Reporting 
All AEs, regardless of seriousness or relationship to the study devices, will be recorded in the EDC 
system and will include event description, date of onset, investigator’s assessment of severity, 
relationship to study devices, and date of resolution/stabilization of the event. All AEs occurring 
while on study must be documented appropriately regardless of relationship. All AEs will be 
followed through end of the study. 
Expectedness 
Definition 
Expected 
AE is consistent with the risk information described in the ICF, IFU and clinical study 
protocol (see Section 17) 
Unanticipated or 
Unexpected 
AE is considered UADE or USADE if it is not consistent with the risk information 
described in the ICF, IFU and clinical study protocol (see Section 17). 

 
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Any pre-existing medical condition that is present at the time of screening will not be reported as 
an AE. The occurrence of diagnostic or elective surgical procedures for a pre-existing condition 
will not be recorded as an AE, unless the condition become more severe or results in an AE. 
Whenever possible, diagnosis or single syndrome should be reported instead of symptoms. The 
investigator should specify the date of onset, severity, action taken with respect to the study 
device(s), corrective treatment/therapy given, additional investigations performed, outcome, and 
his/her opinion as to whether there is a reasonable possibility that the AE was caused by the study 
device(s). 
The investigator should take appropriate measures to follow all AEs until resolution or until 
progression has been stabilized, or until study exit, to ensure the safety of the subjects. If the AE 
continues beyond the last planned visit per protocol and/or the subject withdraws from the study, 
clinical investigators should follow the subjects according to standard of care. 
If a subject decides to withdraw from the study, clinical investigator should follow patients with 
ongoing AEs till resolution according to the standard of care. 
An investigator will submit to the sponsor a report of AEs occurring during this investigation as 
defined in the table below. 
Type of Report 
Submission Schedule 
Device-related AE 
Verbal report or initial entry into the AE CRF within 24 hours from assessment 
followed by written report within 10 working days 
Subject Death 
Verbal report within 24 hours followed by a written report within 2 working 
days 
SAE/SADE/UADE/US
ADE 
Verbal report within 24 hours followed by a written report within 5 working 
days 
The investigator will report the above to the reviewing IRB per the IRB’s guidelines. The study 
sponsor will be responsible for reporting safety events to the Food and Drug Administration (FDA) 
as required per 21 CFR 812 and 21 CFR 803. 
All SAEs (SAE/SADE/UADE/USADE) will be followed until satisfactory resolution; until the 
investigator deems the event to be chronic or the adherence to be stable or until the subject exits 
the study. Other supporting documentation of the event may be requested by the sponsor and 
should be provided as soon as possible.  
All device deficiencies including malfunctions, use errors, and inadequate labeling, will be 
reported to appropriate regulatory bodies and Institutional Review Boards (IRBs) as applicable. 
17 
RISK/BENEFIT ASSESSMENT 
A risk/benefit analysis has been performed and a summary of the results is provided below.   

 
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17.1 
Potential Risks 
Risks associated with balloon dilation of the sinuses, as well as the placement and use of the 
PROPEL Contour Sinus Implant in the FSO are anticipated to be similar to those experienced by 
subjects who undergo balloon dilation of the sinuses as well as placement of other sinus stents.   
Consequently, the risks potentially associated with the use of the sinus balloons may include but 
are not limited to the following:  
 
Epistaxis  
 
Cerebrospinal fluid leak  
 
Pneumocephalus  
 
Damage of the orbital wall or other ocular structures  
 
Impaired or loss of vision  
 
Impaired tearing  
 
Periorbital cellulitis/edema  
 
Infection  
 
Facial/nasal pain  
 
Facial/nasal discomfort  
 
Headache  
Accordingly, the risks potentially associated with the placement of the PROPEL Contour Sinus 
Implant are:  
 
Special care should be taken to avoid bending, twisting or damaging the implant. 
 
The implant is not designed to be modified by the physician. 
 
The implant is not intended to be compressed and loaded into the delivery system more than 
two times. 
 
The implant must be placed under endoscopic visualization. 
 
The implant exhibits no antimicrobial properties. 
 
Foreign body reaction may occur as is possible with most surgical adjuncts. 
 
In rare instances, the physiochemical condition associated with sinus surgery, both with and 
without sinus implants or packing, may present a risk of toxic shock syndrome (TSS). 
 
Pediatric Use: The safety and effectiveness of the implant in pediatric patients have not been 
established. 

 
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 
Pregnancy and Nursing Females: The safety and effectiveness of the implant in pregnant or 
nursing females have not been established. 
Risks or side effects associated with the intranasal use of intranasal mometasone furoate (study 
drug): 
 
Nasal irritation 
 
Hypersensitivity reaction 
 
Intranasal bleeding 
 
Localized infection (bacterial, fungal colonization or viral) in the nose or pharynx 
 
Nasal burning 
 
Nasal dryness 
 
Susceptibility to secondary infections due to bacteria, fungi or viruses 
 
Glaucoma or elevation of intraocular pressure 
 
Cataracts or change in lens opacities 
 
Headache 
 
Pharyngitis 
General side effects associated with steroids: 
 
Alteration of the HPA axis including growth suppression 
 
Immunosuppression 
 
Hypersensitivity reactions  
 
Headache 
 
Epistaxis 
 
Coughing 
 
Vomiting 
 
Candidiasis 
 
Glaucoma/elevation in intraocular pressure 
 
Cataracts or change in lens opacities 
 
Arthralgia 
 
Myalgia 

 
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Inhaled and intranasal mometasone furoate is generally well tolerated in clinical trials and any 
adverse effects are mild and generally of short duration with similar in incidence to placebo.  The 
proportion of subjects discontinuing as a result of adverse events related to treatment is very low 
and generally <2-5% in most trials (Davies 1997, Drouin 1996, Graft 1996, Hebert 1996, Mandl 
1997, McCormack 2006, Nayak 2002, Schenkel 2003).  
Intranasal glucocorticoids may occasionally cause local adverse effects, such as a mild sensation 
of nasal irritation, crusting, dryness and usually minor epistaxis, however these are transient and 
do not worsen during long-term treatment (Mygind 2006).  Local mycotic infections and septal 
perforations with prolonged use of nasal corticosteroids are extremely rare and have not been 
reported for mometasone furoate (Kyrmizakis 2000, Van Cauwenberge 2005, Vogt 1979). These 
findings may be related to the more rapid clearance of the topical corticosteroid by the ciliated 
nasal epithelium. The material used to make the implant has been used extensively in the 
manufacture of suture materials and other implantable medical devices and is not expected to 
present any new risks.  
There are potential risks associated with CT scans with limited and medically acceptable dose of 
radiation.  The radiation exposure from CT scan during this study is considered small and is not 
likely to affect subjects or subjects’ sinus condition. 
17.2 
Minimization of Anticipated Risks 
Risks associated with the PROPEL Contour Sinus Implant are minimized due to: 
 
The use of medical grade materials that have a long history of use and have been 
characterized and tested to assure biocompatibility. 
 
Incorporation of a very low dose (370 mcg) of mometasone furoate, the average daily release 
of which is below currently FDA approved intranasal doses for allergic rhinitis and nasal 
polyps. 
 
Pre-clinical evaluation including bench testing, analytical testing and animal studies. 
 
Prior clinical testing. 
 
Instructions for Use that details appropriate implant preparation and placement. 
 
Routine subject follow-up that includes direct endoscopic visualization of the implant and 
sinus tissue. 
 
In addition, risks will be minimized by including investigators experienced in performing 
sinus surgery and nasal endoscopy.   
17.3 
Potential Risks to Study Subject Confidentiality 
In all clinical studies, confidentiality of protected health information may be breached due to study-
related activities beyond those of routine clinical care.  This risk will be minimized by not 

 
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collecting personally identifying information on CRFs or other study related documentation to be 
provided to the study sponsor.  Any subject’s personal identifying information from any 
documentation will be redacted by the site prior to being sent to Sponsor. 
17.4 
Potential Benefits of Study Participation 
There may be no direct benefits of study participation. However, study subjects will undergo an 
enhanced level of clinical scrutiny compared to routine clinical care, which may provide some 
indirect health benefits. 
The PROPEL Contour Sinus Implant is intended for use in patients ≥ 18 years of age to maintain 
patency of the frontal and maxillary sinus ostia following sinus surgery and locally deliver steroids 
to the sinus mucosa. The PROPEL Contour Sinus Implant separates/dilates mucosal tissues, 
prevents obstruction by adhesions/scarring, and reduces edema. The implant reduces the need for 
post-operative intervention such as surgical adhesion lysis and/or use of oral steroids. Addition of 
mometasone furoate is intended to minimize post-surgical inflammation, potentially reducing the 
frequency of adhesion formation and enhancing the wound healing process.  Subjects may benefit 
from these actions.  Because the implant is bioabsorbable, subjects may be able to avoid use of 
other sinus stents that require removal, which can be uncomfortable. 
17.5 
Risk/Benefit Conclusion 
Based upon the Risk/Benefit Analysis performed by Sponsor, the benefits associated with the sinus 
implant are expected to outweigh the potential risks to the subject, and the anticipated possible 
risks remain reasonable and acceptable. 
18 
STATISTICAL CONSIDERATIONS 
A detailed Statistical Analysis Plan (SAP) will be prepared prior to the primary analysis through 
Day 45. Following is a description of the study sampling plan and a summary of the intended 
analyses. 
18.1 
Randomization 
The ratio of left to right sinus assignments will be 1:1. Following bilateral frontal BSD, eligible 
subjects will receive 1 PROPEL Contour (treatment) on 1 side, and no implant (control) on the 
contralateral side. Randomization will be stratified by site and will follow a blocked scheme, with 
blocks of varying sizes, and will be performed using the envelope method. The randomization 
scheme will be generated by an independent statistician. 
18.2 
Analysis of Primary Efficacy Endpoint 
The detailed hypothesis, data analysis plan for the primary efficacy endpoint, as well as the sample 
size justification will be provided in the SAP. 

 
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18.3 
Analysis of Key Secondary Efficacy Endpoints  
To support potential device labeling claims, a subset of secondary endpoints at Day 45 will be 
identified and analyzed using appropriate methods for controlling for family-wise type error rate 
(FWER). This will be detailed in the SAP that will be prepared prior to the primary analysis.  
18.4 
Analysis of Secondary and Exploratory Endpoints  
Secondary endpoints identified in Section 9.2 and health-economic measures  identified in Section 
9.5 will be analyzed as detailed in the SAP. 
18.5 
Safety Measures 
The incidence of all AEs through Day 180 (end of study) will be reported.  
18.6 
Analysis Populations 
The analysis of the primary and key secondary endpoints at Day 45 will be conducted on the intent-
to-treat (ITT) population. The secondary endpoint analyses will be performed on the ITT and per-
treatment evaluable (PTE) populations through Day 180 as applicable. The exploratory endpoint 
analysis will be performed on the PTE population. The safety will be evaluated on the safety 
population. All analysis populations are defined below: 
 
ITT Population. All randomized subjects and sinuses in whom SBD followed by placement 
of PROPEL Contour in the target sinus was attempted. An attempt occurs when the physician 
introduces the delivery system into the subject’s nostril with the intent of implant placement. 
Subjects’ sinuses are analyzed in the treatment group to which they are randomized. This is 
the main analysis population for the primary and key secondary efficacy endpoints.  
 
PTE Population. All randomized subjects who have received PROPEL Contour in the target 
sinus, who have no major procedural protocol deviations (e.g., underwent study-related 
procedures prior to informed consent, received treatment other than assigned by 
randomization), and for whom follow-up data are available. This population will be used for 
the secondary and exploratory endpoints. 
 
Safety Population. All subjects and sinuses exposed to PROPEL Contour. This population 
will be used for all summaries of AEs. Any subjects enrolled in the study who are not exposed 
to PROPEL Contour will be summarized separately. 
18.7 
Interim Analysis 
No interim analysis will be planned for this study. 
19 
STUDY MANAGEMENT 
As the study sponsor, Intersect ENT has the overall responsibility for the conduct of the study and 
will ensure that the study is conducted under ISO14155 and 21 CFR Parts 11, 50, 54, 56 and 812. 

 
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Personnel who participate in the conduct of this clinical trial will be qualified by education and 
experience as applicable prior to performing their tasks. 
19.1 
Ethical Considerations 
The rights, safety and well-being of human subjects, which are the most important considerations 
and shall prevail over interests of science and society. These principles shall be understood, 
observed, and applied at every step in the clinical investigation.  The sponsor shall avoid improper 
influence on, or inducement of, the subject, monitor, any investigator(s) or other parties 
participating in, or contributing to, the clinical investigation. All investigators shall avoid improper 
influence on or inducement of the subject, sponsor, monitor, other investigator(s) or other parties 
participating in or contributing to the clinical investigation.  The rights, safety and well-being of 
clinical investigational participants shall be protected in accordance with the ethical principles 
based in the Declaration of Helsinki (Rickham 1964).  
Written informed consent shall be obtained in writing from the subject and the process shall be 
documented before any procedure specific to the clinical investigation is applied to the subject.  
All local competent authority, Institutional Review Board (IRB) and local requirements will be 
followed.  IRB approval will be documented and obtained prior to study start at the applicable site.   
It is expected that all parties will share in the responsibility for ethical conduct in accordance with 
their respective roles in the investigation.  
19.2 
Sponsor Responsibilities 
Intersect ENT, as the study sponsor, has the overall responsibility for the conduct of the study and 
will ensure that the study is conducted under the guidance of International Council on 
Harmonization (ICH) Good Clinical Practice (GCP) (E6), Clinical investigation of medical 
devices for human subjects – Good clinical practice (ISO 14155) and other applicable local and 
federal (e.g., 21 CFR Parts 11, 50, 54, 56, and 812) regulations, including the archiving of essential 
documents. A list of the names, locations, and chairpersons of all IRBs (including actions taken 
by each IRB on the protocol) that have been or will be asked to review the protocol will be kept 
on file. Qualified personnel who participate in the conduct of this clinical trial will be qualified by 
education and/or experience and trained to perform their tasks. Intersect ENT will not use, in any 
capacity, the services of any person debarred under section 306 of the Federal Food, Drug, and 
Cosmetic Act in connection with this clinical study.  
19.3 
Blinding 
The independent reviewer of CT images will be blinded to treatment assignment. Subjects, treating 
investigators and clinical research coordinators will be unblinded, as they will be attending the 
placement procedure.  

 
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19.4 
Training 
Sponsor personnel or designee will provide all clinical investigators performing procedures with 
training on use of the PROPEL Contour Sinus Implant, VenSure Nav Balloon Device, Inflation 
Device and Cube Navigation System prior to their participation in the clinical study. The study 
center staff involved will undergo training at site initiation (or separately) which will include: 
 
Study protocol 
 
Consenting procedures and Human Subjects Protection 
 
Instructions for use 
 
Investigator responsibilities, including reporting requirements 
 
Monitoring and auditing 
 
EDC system 
 
Electronic recordkeeping 
 
Endoscopic assessments 
 
EXPAND study devices accountability procedures 
 
Protection of subject confidentiality 
CRF completion guidelines, CT imaging acquisition guidelines, and Imaging Site User Manual 
will be provided to sites.  Applicable site staff will be trained to uploading CT imaging to Core 
Laboratory portal prior to commencing such activity.  
New members of the investigation site team may be added from time to time at new or existing 
sites. New personnel should only start their assignment after receiving adequate training in the 
clinical investigation requirements and this training shall be documented. The names, initials, 
signatures, functions, and designated authorizations of new site personnel shall be documented. 
19.5 
Protocol Deviations 
Any deviation from the requirements outlined in this protocol will be considered a protocol 
deviation. A protocol deviation that may affect the scientific soundness of the protocol or the 
rights, safety, or welfare of the subjects should be reported to the sponsor and the Institutional 
Review Board (IRB) as soon as possible. Other deviations are those that occur in direct association 
with a specific study subject. These include, but are not limited to, deviations from the informed 
consent process, inclusion/exclusion criteria, protocol-specified procedures and assessments, and 
EXPAND study device handling and usage. All efforts should be made to avoid any protocol 
deviation. 

 
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19.6 
Monitor Responsibilities 
Study site monitoring will be performed by trained and qualified personnel from Sponsor or their 
designee.  A list of monitors will be maintained by Sponsor and will be available upon request. 
Study sites will be monitored regularly to ensure that the study is conducted under ISO14155 and 
21 CFR Parts 11, 50, 54, 56, 812, the study protocol, IRB requirements, and other applicable 
regulations.  Study monitors will also ensure that the data reported in Electronic Data Capture 
(EDC) database is accurate, complete, and consistent with the information found in the subject’s 
medical records and source documents as part of source document verification. Monitoring will 
include assessment of the site’s overall enrollment progress, the site’s ability to maintain and report 
accurate, complete, and consistent records and to report study related data, including AEs, 
complaints, and device malfunctions and deficiencies, to the study sponsor in a timely fashion.  In 
order to appropriately monitor the progress of the study, the monitor will have access to the site 
source documents and other information necessary to ensure investigator compliance with the 
protocol and applicable rules and regulations and to assess the progress of the clinical 
investigation.   
The study monitors will maintain personal contact with investigators and study coordinators by 
phone, e-mail, mail and on-site/remote visits.  Monitoring will be performed periodically during 
the period of subject enrollment through final database lock.  The schedule of monitoring at 
individual clinical sites will be determined based on factors such as enrollment number and rate, 
presence of new clinical investigators, training needs, protocol compliance and individual clinical 
site needs.  The monitor will complete a monitoring report for each visit which will be provided 
to the sponsor.  
Letters documenting the visit and relevant findings will be provided to the site.  Monitoring will 
ensure continued protocol compliance and accurate reporting of data, AEs, complaints, device 
deficiencies and malfunctions, protocol deviations and product accountability. 
Appropriate source data verification will be performed on efficacy and safety data for each subject 
enrolled in this study. 
19.7 
Data Management Responsibilities 
Data management will be performed by the sponsor. 
Electronic data capture 
An EDC system will be utilized to capture study data and compliant with 21 CFR Part 11 and 
under the guidance of ‘FDA Guidance for Industry: Computerized Systems Used in Clinical 
Investigations’. The EDC will be validated and verified prior to use, and validation and verification 
and release documentation will be maintained on file by the study sponsor. Data entry will be 
performed by site personnel after completing an appropriate training. Modifications to the EDC 
will be made if deemed necessary by the study sponsor. 
Data cleaning 

 
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The database will be subject to initial inspection for omitted data, gross data inconsistencies, and 
deviations. Any deficiencies or deviations will be reviewed, and any necessary action determined 
(e.g., data query, communication with the study center). 
 Intermittent data review will be performed, and any discovered errors will be reported to the study 
site using the electronic query process (as necessary). The study site will be expected to review 
and complete the query. The data cleaning cycle will be repeated until all data are considered clean. 
Data back-up, confidentiality and security 
Incremental data back-up will be performed on a regular basis by the EDC system vendor. All 
media will be stored in a secure location. Passwords will be issued to appropriate personnel to 
ensure confidentiality and protection of data. 
19.8 
Investigator Responsibilities 
General responsibilities  
 
Each investigator is responsible for ensuring that an investigation is conducted per the signed 
investigator statement (Investigator Agreement/Commitment), the study protocol, and 
applicable regulations; for protecting the rights, safety, and welfare of study subjects under 
the investigator’s care and for the control of drugs/devices under investigation.  
 
The investigator shall assure the accuracy, completeness, legibility and timeliness of the data 
reported to the sponsor on the CRFs and in all required reports.  
 
Each investigator shall obtain informed consent of each patient to whom the treatment is 
administered in accordance with provisions of 21 CFR Part 50 and ISO14155.  
 
Each investigator (designee) is responsible for all applicable IRB requirements under 21 CFR 
Part 56 and ISO14155.  
 
Each investigator is responsible for disclosure of financial obligations/conflict of interest to 
the sponsor in accordance with provisions of 21 CFR Part 54.  
 
The study will be conducted under 21 CFR 11, 50, 54, 56, 812 and ISO14155. Investigators 
will be trained on their responsibilities.  
 
To ensure proper execution of the study protocol, each investigator will identify a study 
coordinator(s) for this study. Working with and under the oversight of the principal 
investigator, the study coordinator(s) ensures that all study requirements are fulfilled.  
 
Each investigator will allow monitoring and auditing of their clinical investigation 
procedure(s) by the sponsor or designee.  
Control and disposition of the study devices  
An investigator shall administer the EXPAND study devices only to subjects under the clinical 
investigator’s personal supervision. The investigator shall not supply the EXPAND study device 

 
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to any person not authorized to receive it. An investigator (or designee) is required to maintain 
adequate records of the disposition of the study devices, including dates, quantity, and use by 
subjects. All unopened unused devices must be returned to the sponsor.  
Required documents from study centers  
At a minimum, the following documents will be provided by the study center to the study 
sponsor:  
 
IRB study approval letter  
 
IRB approved informed consent  
 
Fully executed clinical trial agreement (CTA)  
 
Investigator agreement/commitment for the participating investigator(s)  
 
Financial disclosure form for the participating investigator(s)  
 
Curriculum vitae (CV) for the participating investigator(s)  
 
Current medical license for the participating investigator(s)  
 
Principal investigator protocol acknowledgement form  
A site may not begin active enrollment of patients until the documentation for the site principal 
investigator has been provided to the sponsor and the sponsor has provided written approval to 
begin enrollment.  
 
To ensure proper execution of the study protocol, each investigator should identify a study 
coordinator for this study.  Working with and per delegated authority of the principal investigator, 
the study coordinator assures that study requirements are fulfilled. 
The investigator will permit collection and review of the site’s standard operating procedure(s) by 
monitors, as well as on-site/remote auditing of the clinical study upon request. 
Maintenance of Study Records 
The investigator is responsible for maintaining medical and study records for every subject 
participating in the clinical study (including information maintained electronically such as digital 
imaging), from enrollment through study exit.  The investigator will also maintain original source 
documents from which study-related data are derived, which may include, but are not limited to: 
 
Clinic progress notes recording subject’s medical history and medications 
 
Medical charts with operative reports and condition of subject upon discharge 
 
Medical records regarding AEs, including treatment and clinical outcome 
 
Results of diagnostic examinations 
 
Imaging (e.g., x-rays, CT scans) 

 
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 
Notes of phone calls and/or correspondence indicating investigational site’s attempts to 
follow study subjects at the required follow-up visits until subject’s participation in the study 
is complete or terminated 
 
Records relating to subject death (e.g., death certificate, autopsy report) 
 
Printouts of source data generated by technical equipment (e.g., CT, MRI) must be filed with 
the subject’s records.   
The study investigator must ensure that all study subject records and study regulatory 
documentation pertaining to the clinical study are stored per regulatory body requirements.  To 
avoid error, the study site should contact the study sponsor prior to the destruction of study records 
to ensure that they no longer need to be retained.  In addition, the Sponsor should be contacted if 
the investigator plans to leave the study site so that arrangements can be made for the handling or 
transfer of study records. 
19.9 
Protection of Subject Confidentiality 
In all clinical studies, confidentiality of protected health information may be breached due to study-
related activities beyond those of routine clinical care. This risk will be minimized by not collecting 
personally identifying information on CRFs or other study related documentation to be provided 
to the study sponsor. It is the sponsor’s policy to redact any subject’s personally At all times 
throughout the clinical investigation, confidentiality will be observed by all parties involved. All 
data shall be secured against unauthorized access. Privacy and confidentiality of information about 
each subject shall be preserved in the reports and in any publication. Each subject participating in 
this study will be assigned a unique identifier. All database forms and source documents sent to 
the sponsor will be tracked, evaluated, and stored using only this unique identifier. 
Clinical investigators will maintain confidential study subject lists identifying all enrolled subjects. 
The clinical investigators bear responsibility for keeping these lists current and confidential. These 
lists will not be provided to the study sponsor. 
Monitors and auditors will have access to the study screening and enrollment logs and other 
personally identifying information of study subjects to ensure that data reported in the EDC 
corresponds to the person who signed the ICF and the information contained in the original source 
documents. Such personal identifying information may include, the subject’s name, address, date 
of birth, gender, race, and medical record number. 
The subject’s name, medical record number or address will not be recorded in the monitor’s visit 
report or the database. Demographic data that may be recorded include age, race, and gender. Any 
source documents copied for monitoring purposes by the sponsor will be identified by using the 
assigned subject’s unique identifier in an effort to protect subject confidentiality. All personally 
identifiable information will be redacted from source documents. 

 
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19.10 
Study Suspension or Early Termination 
The study can be discontinued at the discretion of the investigator or study sponsor for reasons 
including, but not limited to, the following: 
 
Occurrence of AEs unknown to date in respect to their nature, severity, or duration, or the 
unexpected incidence of known AEs 
 
Obtaining new scientific knowledge that shows that the study is no longer valid or necessary 
 
Insufficient recruitment of subjects 
 
Unanticipated adverse device effect (UADE) or unanticipated serious adverse device effect 
(USADE) presenting an unreasonable risk to subjects (sponsor may terminate the study 
immediately) 
 
Persistent non-compliance with the protocol 
 
Persistent non-compliance with applicable ethics committee or regulatory requirements 
 
Sponsor decision to terminate study 
If the study is discontinued or suspended prematurely, the sponsor shall promptly inform all 
clinical investigator(s)/study center(s) of the termination or suspension and the reason(s) for this.  
The IRB shall also be informed promptly and provided with the reason(s) for the termination or 
suspension by the sponsor or by the clinical investigator/investigation center(s).  Regulatory 
authorities and the personal physicians of the subjects may also need to be informed if deemed 
necessary and provided any blinding information to assist with patient care.   
19.11 
Site Closeout 
At the time of the site close-out, the monitor will have ensured all outstanding study documents 
are reconciled, the investigator’s files are accurate and complete, have reviewed record retention 
requirements with the investigator, made a final accounting of all study supplies, and ensured that 
all applicable requirements are met for the study. Any specific observations and actions made at 
this visit may be documented in a final monitoring report. 
19.12 
Quality Assurance and Supervision by Authorities 
All documents and data shall be produced and maintained in such a way to assure control of 
documents and data to protect the subject’s privacy as far as reasonably practicable.  The sponsor 
and representatives of the FDA, IRB or other regulatory authorities are permitted to inspect the 
study documents (e.g., study protocol, CRFs, and original study-relevant medical records/files) as 
needed.  All attempts will be made to preserve subject confidentiality. 
The study centers are subject to audit by study sponsor personnel or designee for protocol 
adherence, accuracy of CRFs and compliance with applicable regulations.  The sponsor will 
communicate to the site any patterns of non-compliance. The sponsor will work with the site to 

 
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determine any necessary corrective action, as applicable. The sponsor will continue to monitor the 
site until compliance has been secured. If the site continues to display non-compliance, further and 
more serious action may be taken by the study sponsor. 
The study protocol, data-recording procedures, data handling as well as study reports are subject 
to an independent clinical Quality Assurance audit by the Sponsor, its designee, or health 
authorities. 
19.13 
Approved ICF and Protection of Study Subject 
An IRB must review and approve an informed consent form (ICF) specific to this study, prior to 
consent of a study subject.  Sponsor will provide the sites with an ICF template, which the site 
may modify to include site-specific contact information and site-specific IRB requirements.  
Sponsor must approve all site-modified informed consent forms prior to use in consenting a 
subject.  IRB approvals and approval renewals of all versions of the site ICF will be provided to 
sponsor and maintained by the site for the duration of the study.  The original, signed and dated 
ICF for each subject should be retained by the site for monitoring.  
Subjects will be informed both verbally and in writing (i.e., ICF) about the nature of the study, the 
anticipated risks and benefits involved and the discomfort to which they will be exposed. They 
will be instructed about their right to discontinue their participation at any time without prejudice 
or jeopardy to future medical care. They must confirm consent in writing prior to any screening 
procedures. A copy of the informed consent will be provided to the subject.  
19.14 
IRB Approval 
The study protocol and ICF must be approved prior to study commencement under 21 CFR Part 
56. A justification of the non-significant risk determination of the study and any supporting 
information, as necessary, will be provided to the IRB under 21 CFR 812.2(b). Clinical 
investigators must also obtain renewal of IRB approval throughout the duration of the study. 
Clinical investigators are responsible for fulfilling any conditions of approval imposed by the 
reviewing IRB, such as regular reporting, study timing, etc. Clinical investigators will provide the 
study sponsor with copies of such approvals and reports. 
19.15 
Other Investigator Reports 
The investigator is responsible for the generation of the following reports according to the 
following schedule: 
 
NOTE:  Reports must be redacted of any personal identification information to protect subject’s confidentiality. 
Type of Notification 
Timeline 
Withdrawal of IRB Approval 
Initial report within 24 hours followed by a written report 
within 5 working days 
Informed Consent Not Obtained 
written report within 24 hours of identification 

 
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19.16 
Final Clinical Study Report 
A final clinical study report (CSR) will be prepared by the study sponsor and provided to the 
regulatory agency, as needed. 
20 
PUBLICATION POLICY 
At the conclusion of the study, an abstract reporting the results will be prepared and may be 
presented at a scientific meeting(s). A manuscript may also be prepared for publication in a peer-
reviewed scientific journal. Co-authorship will be granted to the National PI and those site PIs 
from the top enrolling sites. Consistent with “Recommendations for the Conduct, Reporting, and 
Publication of Scholarly Work in Medical Journals”, every author should meet the following for 
authorship:  
 
Substantial contributions to the conception or design of the work; or the acquisition, analysis, 
or interpretation of data for the work; and  
 
Drafting the work or revising it critically for important intellectual content; and  
 
Final approval of the version to be published; and  
 
Agreement to be accountable for all aspects of the work in ensuring that questions related to 
the accuracy or integrity of any part of the work are appropriately investigated and resolved.  
The study will also be registered in publicly accessible databases (e.g., ClinicalTrials.gov) per 
applicable regulation. 
21 
COVID -19 CONTIGENCY MEASURES 
This section identifies contingency measures for the study procedures and various aspects of 
study management to address limitations to study site visits imposed by the COVID-19 pandemic 
in accordance with “FDA Guidance on Conduct of Clinical Trials of Medical Products 
during COVID-19 Public Health Emergency” (March 2020, updated on August 30th, 2021).   
21.1 
Study Procedures During COVID-19 
 
The implementation of contingency measures should be consistent with the protocol to the 
extent possible, and sponsor and clinical investigators should document the reason for any 
contingency measures implemented.   
 
Informed consent and Screening: The ICF may be sent to prospective subjects for review and 
discussed remotely via phone contact or virtual visit but it must be signed and dated during 
on-site visit prior to and on the same day as the protocol-required screening assessments to 
confirm initial eligibility and obtain baseline values. In the event that new information 
requires a subject be re-consented, the updated ICF may be sent to the subject electronically 
or via mail for review and discussed remotely via phone contact or virtual visit. The consent 
form can be signed, scanned and returned electronically to the site, returned by mail using a 

 
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Clinical Study Protocol P500-1220 (The EXPAND Study) 
Doc# CP-00030 Rev. 5.0, 26 May 2022 
prepaid envelope provided by the site, or returned in person. COVID-19 screening 
procedures that may be mandated by the clinical sites do not need to be entered into EDC. If 
a potential subject tests positive for COVID-19, the subject is considered screen failure.    
 
Follow-up Visit: If COVID-19 restrictions or subject’s health status prevent the subject from 
attending a protocol-required on-site visits, those visits can be conducted remotely. The 
protocol-required CT and endoscopic assessment on baseline and follow-up visits shall be 
conducted on-site to maintain data quality and integrity for the primary and key secondary 
efficacy endpoints. If a subject completes the follow up visits out of window because of 
COVID-19, this will be reported as a protocol deviation with COVID-19 as a reason. The 
data from these late visits can be leveraged based on scientifically based rationale and clinical 
judgement.   
 
CT and endoscopy assessment: If the CT or endoscopy assessment cannot be completed 
within the visit window, they can either be completed within reasonable (< 30 days) from 
the visit window or be left as not done. These will be reported as a protocol deviation with 
COVID-19 as a reason. 
 
SNOT-22, RSI and CRS side-specific symptom questionnaire: The study staff can mail the 
paper questionnaires to the subject’s home for completion during a virtual study visit. The 
completed and initialed questionnaires can be returned to the site in person or 
using envelopes provided by the study site. The visit type will be recorded in the EDC.   
 
Reporting of any AEs, device deficiencies and change in concomitant medications:  These 
can be completed during virtual visit and documented in the EDC.   
21.2 
Contingency Measures for Study Management 
 
SIV training: The required training can be completed through web-based self-training or in 
person through video conferencing. The training must be documented.  
 
Data monitoring: In the event an in-person study site visit is not permissible, CRAs 
will perform remote monitoring. Remote monitoring will include remote source data 
verification and collection of essential documents. Remote performance of source data 
verification will require the site research coordinator to redact, scan and send certified copies 
of source documents to a secure, cloud-based portal or through email. Redacted copies 
should be kept in the investigator's site master file with records of their communication to 
the monitor. Uploaded source documents will be accessed by site monitors for source 
verification with entries in EDC. Issues identified and their resolution will be tracked through 
annotations made in EDC. Discrepancies between source and EDC will be managed 
and documented through the EDC query resolution process. Once source data verification 
is complete, the CRA will securely destroy any copy made locally and provide a certificate 
of destruction to the trial site.  

 
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Clinical Study Protocol P500-1220 (The EXPAND Study) 
Doc# CP-00030 Rev. 5.0, 26 May 2022 
 
EMR system: If local study site policies allow access to the site EMR system, collection of 
electronic medical records may be completed using the same process. If local study site 
policies allow access to the site EMR system, the CRA should be provided with secure, read-
only access, including all modules relevant for review. This access should be restricted to the 
records of only those patients who participate in the trial. A list of the monitors to whom 
remote access has been granted should be maintained. In order to prevent unauthorized 
access, access rights should be revoked once remote SDV tasks have been completed for the 
trial. The EMR system should have an audit trail and be able to log information on who 
accessed data and when. Remote access to the EMR should only be possible using a two-
factor authentication. It should not be possible to make local copies of trial participants' 
health records. Users should be aware of the automatic creation of temporary files on their 
computer when reviewing trial participant data and should securely delete such files 
immediately after each source data verification session. 
 
Situations where CRAs were unable to access or had delayed monitoring of a clinical site 
shall be documented, including whether identification of deviations or GCP non-compliance 
was delayed due to postponed monitoring findings and action items resulting from 
remote monitoring can be discussed with PI and site coordinator via teleconference. 
Monitoring activities shall be documented per normal procedure.  
 
Reporting of protocol deviations: When a deviation is the result of a COVID-19 limitation, 
the deviation report shall include the specific limitation imposed by COVID-19 leading to 
the inability to comply with the protocol.    
 

 
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Clinical Study Protocol P500-1220 (The EXPAND Study) 
Doc# CP-00030 Rev. 5.0, 26 May 2022 
22 
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Clinical Study Protocol P500-1220 (The EXPAND Study) 
Doc# CP-00030 Rev. 5.0, 26 May 2022 
Singh A, Luong AU, Fong KJ, et al. Bioabsorbable steroid-releasing implants in the frontal sinus 
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Internal Document 
CP-00038 Radiographic Evaluation Protocol for P500-1220 (The EXPAND Study), Rev 2.0, 18 
May 2022 

 
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May not be reproduced outside of Intersect ENT without written permission from Document Control. 
Clinical Study Protocol P500-1220 (The EXPAND Study) 
Doc# CP-00030 Rev. 5.0, 26 May 2022 
APPENDIX I:  LIST OF CORTICOSTEROID MEDICATIONS 
 
Trade Name 
(alphabetical order) 
Generic Name 
Route of Administration 
Budesonide 
Pulmicort Respules 
Budesonide 
Nasal (e.g., irrigations, rinses) 
Decadron 
Dexasone 
Dexamethasone 
Intramuscular 
Oral 
Depo Medrol 
Medrol 
Medrol Dosepak  
Methylprednisolone 
Methylprednisolone 
Methylprednisolone Acetate 
Oral  
Parenteral routes (e.g., intra-
articular, intra-cervical) 
Flovent 
Flonase  
Xhance  
Fluticasone Propionate 
Fluticasone Propionate w/Salmeterol 
Nasal irrigations 
Intranasal sprays 
Kenalog 
Triamcinolone 
Triamcinolone Acetonide 
Intramuscular 
Subcutaneous 
Submucosal 
Nasonex  
Mometasone furoate 
Nasal irrigations 
Intranasal sprays 
Deltasone 
Prednicot 
Sterapred 
Prednisone 
Intramuscular 
Oral