Randomized Trial of Propel Stent vs Kenalog-soaked Nasopore After Frontal Drill-out
Phase: NA
Conditions: Stent, Sinusitis, Frontal
Sponsor: St. Louis University

 
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 28525
 Date Printed: 04/20/2018
Personnel Information
1
Subject Population
8
Study Location
9
General Checklist
9
Funding
10
Expedited Paragraphs
10
Background, Purpose, Study Procedures
12
Radioisotopes or Radiation Machines
19
Devices
20
Drugs, Reagents, Chemicals, or Biologic Products
22
Other Levels Of Review
24
Subject Population
25
Subject Population
27
Risks
28
Benefits/Alternatives, Procedures to Maintain Confidentiality and Privacy
33
Potential Conflict of Interest
38
Informed Consent
39
Assent
41
HIPAA
41

Page 1 of 43
SLU eIRB
1
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
------------------------------------------------------------------------------
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after
Frontal Drill-out
Protocol Status:
APPROVED
Date Submitted:
04/12/2018
Approval Period:
04/13/2018-11/20/2018
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
* * * Personnel Information * * *
Study Personnel Roles:
-Principal Investigator: accepts responsibility for study, must sign obligations, can edit protocol and submit to IRB
-Administrative Contact: additional study contact, may or may not also be member of research team, can
edit/prepare protocol and submit to IRB
-Key Personnel (Research Team): SLU member of research team, can view protocol (not edit)
-Non-SLU Collaborator: member of research team from another institution or organization outside of SLU, has no
access to system, must be provided with PDF of protocol. NOTE: SLUH/SSM employees who collaborate
regularly may obtain a guest SLU account if access to system is needed.
-Department Chair: Official Department Chair, may or may not also be a member of research team, can view the
protocol (not edit). NOTE: a proxy may be listed if the Chair is the PI.
IMPORTANT NOTE: Human Subjects Protection Training is mandatory for all research team personnel.
Principal Investigator (PI)   Mandatory
PI must be SLU affiliate.
Name of Principal Investigator
(Faculty, Staff or Student)
Degree (MD/PhD)
Title
Brunworth, Joseph
MD
Assistant Professor
Email
Phone
Fax
brunworth@slu.edu
314-577-8884
Department Name
 
 
Otolaryngology
 
 
Human Subjects Training Completed?
WARNING: Proof of training must show below or the application will be
returned. If your training information isn't showing, upload a copy in the
Attachments section.
Y
Research Experience              *?HELP?*
As a fellowship trained Otorhinolaryngologist, Dr. Brunworth has been involved in clinical and basic science
research for the last 11 years. He serves as the scientific reviewer for OTO's protocols and is OTO's
Director of Clinical Research.
Research Team Member Duties Picklist
1.
X Recruitment
2.
X Obtains consent
3.
X Determine Subject Eligibility for Accrual
4a.
X Subject Physical Examinations
4b.
X Follow-up Visits including physical
assessments
5.
X Perform study procedures or Specimen
Collection
6a.
X Administer and/or Dispense Study Drugs,
Biologics or Devices (must be licensed)
6b.
X Receive, Store, Manipulate or Account for
Study Drugs, Biologics or Devices
7.
X Subject Randomization or Registry
8.
X Collection of Subject Data

Page 2 of 43
SLU eIRB
2
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
9.
X Report Data (CRFs, e-CRFs, Spreadsheets)
10.
X Data Analysis
11a.
X Review Adverse Events
11b.
X Treat and Classify Adverse Events
12.
Other (Please insert explanation below.)
 
 
UserID
CourseCompletionDate
Course
brunworth
2014-10-27
CITI Biomedical Research Basic
Training
 
Administrative Contact
Name of Administrative Contact
Degree
Title
Patel, Kunjan
BA
Student
Webb, Deniece
BA
Research Coordinator
Gresham, Malia
MD
Otolaryngology Resident
Cass, Lauren
MD, MPH
Otolaryngology Resident
Administrative Contact
Name an Administrative Contact if someone in addition to the PI should be contacted about the protocol.
Name of Administrative Contact
Degree
Title
Patel, Kunjan
BA
Student
Email
Phone
Fax
kpatel65@slu.edu
6306393886
Department Name
 
Otolaryngology
 
Is this individual also a member of the research team?
Y
Human Subjects Training Completed?
WARNING: Proof of training must show below or the application will be
returned. If your training information isn't showing, upload a copy in the
Attachments section.
Y
Research Experience      ?HELP?
Kunjan has been involved in clinical and basic science research in genetics, otolaryngology, and
telemedicine at SLU School of Medicine and Washington University School of Medicine for 6 years. He has
completed multiple clinical projects working with Otolaryngology faculty at SLU School of Medicine.
Research Team Member Duties Picklist
1.
Recruitment
2.
X Obtains consent
3.
Determine Subject Eligibility for Accrual
4a.
Subject Physical Examinations
4b.
Follow-up Visits including physical
assessments
5.
Perform study procedures or Specimen
Collection

Page 3 of 43
SLU eIRB
3
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
6a.
Administer and/or Dispense Study Drugs,
Biologics or Devices (must be licensed)
6b.
Receive, Store, Manipulate or Account
for Study Drugs, Biologics or Devices
7.
X Subject Randomization or Registry
8.
X Collection of Subject Data
9.
X Report Data (CRFs, e-CRFs, Spreadsheets) 10.
X Data Analysis
11a.
Review Adverse Events
11b.
Treat and Classify Adverse Events
12.
Other (Please insert explanation below.)
 
 
UserID
CourseCompletionDate
Course
kpatel65
2012-03-27
CITI Biomedical Research Basic
Training
Name an Administrative Contact if someone in addition to the PI should be contacted about the protocol.
Name of Administrative Contact
Degree
Title
Webb, Deniece
BA
Research Coordinator
Email
Phone
Fax
deniecewebb@slu.edu
(314) 577-8884
Department Name
 
Otolaryngology
 
Is this individual also a member of the research team?
N
Human Subjects Training Completed?
WARNING: Proof of training must show below or the application will be
returned. If your training information isn't showing, upload a copy in the
Attachments section.
Research Experience      ?HELP?
Research Team Member Duties Picklist
1.
Recruitment
2.
Obtains consent
3.
Determine Subject Eligibility for Accrual
4a.
Subject Physical Examinations
4b.
Follow-up Visits including physical
assessments
5.
Perform study procedures or Specimen
Collection
6a.
Administer and/or Dispense Study Drugs,
Biologics or Devices (must be licensed)
6b.
Receive, Store, Manipulate or Account
for Study Drugs, Biologics or Devices
7.
Subject Randomization or Registry
8.
Collection of Subject Data
9.
Report Data (CRFs, e-CRFs, Spreadsheets) 10.
Data Analysis
11a.
Review Adverse Events
11b.
Treat and Classify Adverse Events
12.
Other (Please insert explanation below.)
 
 
UserID
CourseCompletionDate
Course
deniecewebb
2016-02-23
Good Clinical Practice (GCP)
deniecewebb
2016-01-13
CITI Biomedical Research Basic
Training
Name an Administrative Contact if someone in addition to the PI should be contacted about the protocol.

Page 4 of 43
SLU eIRB
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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
Name of Administrative Contact
Degree
Title
Gresham, Malia
MD
Otolaryngology Resident
Email
Phone
Fax
msgresham@slu.edu
314-577-8884
Department Name
 
Otolaryngology
 
Is this individual also a member of the research team?
Y
Human Subjects Training Completed?
WARNING: Proof of training must show below or the application will be
returned. If your training information isn't showing, upload a copy in the
Attachments section.
Y
Research Experience      ?HELP?
Dr. Gresham is an otolaryngology resident and is engaged in the study and treatment of sinonasal
disorders. She has three years of experience in clinical research with projects on topics such as skull base
tumors and craniofacial trauma.
Research Team Member Duties Picklist
1.
X Recruitment
2.
X Obtains consent
3.
X Determine Subject Eligibility for Accrual
4a.
X Subject Physical Examinations
4b.
X Follow-up Visits including physical
assessments
5.
Perform study procedures or Specimen
Collection
6a.
Administer and/or Dispense Study Drugs,
Biologics or Devices (must be licensed)
6b.
Receive, Store, Manipulate or Account
for Study Drugs, Biologics or Devices
7.
X Subject Randomization or Registry
8.
X Collection of Subject Data
9.
X Report Data (CRFs, e-CRFs, Spreadsheets) 10.
X Data Analysis
11a.
Review Adverse Events
11b.
Treat and Classify Adverse Events
12.
Other (Please insert explanation below.)
 
 
UserID
CourseCompletionDate
Course
msgresham
2017-10-30
CITI Biomedical Research Basic
Training
Name an Administrative Contact if someone in addition to the PI should be contacted about the protocol.
Name of Administrative Contact
Degree
Title
Cass, Lauren
MD, MPH
Otolaryngology Resident
Email
Phone
Fax
lcass@slu.edu
314-577-8884
Department Name
 
Otolaryngology
 
Is this individual also a member of the research team?
Y

Page 5 of 43
SLU eIRB
5
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
Human Subjects Training Completed?
WARNING: Proof of training must show below or the application will be
returned. If your training information isn't showing, upload a copy in the
Attachments section.
Y
Research Experience      ?HELP?
As an otolaryngology resident, Dr. Cass is actively involved with treating patients with medical and surgical
sinonasal disease. She has been involved with medical and clinical research for eight years as a medical
student and resident working on various hospital-based and large dataset-based projects. Additionally, she
has earned her Masters in Public Health with training in biostatistics, epidemiology, and study design.
Research Team Member Duties Picklist
1.
X Recruitment
2.
X Obtains consent
3.
X Determine Subject Eligibility for Accrual
4a.
X Subject Physical Examinations
4b.
X Follow-up Visits including physical
assessments
5.
Perform study procedures or Specimen
Collection
6a.
Administer and/or Dispense Study Drugs,
Biologics or Devices (must be licensed)
6b.
Receive, Store, Manipulate or Account
for Study Drugs, Biologics or Devices
7.
X Subject Randomization or Registry
8.
X Collection of Subject Data
9.
X Report Data (CRFs, e-CRFs, Spreadsheets) 10.
X Data Analysis
11a.
Review Adverse Events
11b.
Treat and Classify Adverse Events
12.
Other (Please insert explanation below.)
 
 
UserID
CourseCompletionDate
Course
lcass
2011-01-01
CITI Biomedical Research Basic
Training
lcass
2008-11-03
CITI Social/Behavioral Research
Basic Training
 
Key Personnel (Research Team)
Name of Key Personnel
(Research Team)
Degree
Title
Department Name
Simpson, Matthew
MPA
Research Assistant, Sr.
Otolaryngology
 
 
Department Chair  Mandatory
The official Department Chair should be listed here. If the Department Chair is the PI, a proxy may be listed.
Name of Department Chair
Degree
Title
Antisdel, Jastin
MD
Associate Professor
Email
Phone
Fax

Page 6 of 43
SLU eIRB
6
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
antisdel@slu.edu
(314) 577-8885
Department Name
 
 
Otolaryngology
 
 
Is this individual also a member of the research team?
Y
Human Subjects Training Completed?
WARNING: Proof of training must show below or the application will be
returned. If your training information isn't showing, upload a copy in the
Attachments section.
Y
Research Experience      *?HELP?*
Dr. Antsidel has 18 years experience in clinical research from med school through a rhinology fellowship and 8
years in academic medicine.
Research Team Member Duties Picklist
1.
X Recruitment
2.
X Obtains consent
3.
X Determine Subject Eligibility for Accrual
4a.
X Subject Physical Examinations
4b.
X Follow-up Visits including physical
assessments
5.
X Perform study procedures or Specimen
Collection
6a.
X Administer and/or Dispense Study Drugs,
Biologics or Devices (must be licensed)
6b.
X Receive, Store, Manipulate or Account for
Study Drugs, Biologics or Devices
7.
X Subject Randomization or Registry
8.
X Collection of Subject Data
9.
X Report Data (CRFs, e-CRFs, Spreadsheets)
10.
X Data Analysis
11a.
X Review Adverse Events
11b.
X Treat and Classify Adverse Events
12.
Other (Please insert explanation below.)
 
 
UserID
CourseCompletionDate
Course
antisdel
2017-03-08
Good Clinical Practice (GCP)
antisdel
2007-02-19
CITI Biomedical Research Basic
Training
 
Research Team Roles
Name(s), Degree
Department
Experience
Duties
 Brunworth, Joseph, MD
Otolaryngology
As a fellowship trained
Otorhinolaryngologist, Dr.
Brunworth has been
involved in clinical and basic
science research for the last
11 years. He serves as the
scientific reviewer for OTO's
protocols and is OTO's
Director of Clinical
Research.
 Recruitment, Obtains
consent, Determine
Subject Eligibility for
Accrual, Subject Physical
Examinations, Follow-up
Visits including physical
assessments, Perform
study procedures or
Specimen Collection,
Administer and/or
Dispense Study Drugs,
Biologics or Devices
(must be licensed),
Receive, Store,
Manipulate or Account for
Study Drugs, Biologics or

Page 7 of 43
SLU eIRB
7
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
Devices, Subject
Randomization or
Registry, Collection of
Subject Data, Report Data
(CRFs, e-CRFs,
Spreadsheets), Data
Analysis, Review Adverse
Events, Treat and Classify
Adverse Events
 Patel, Kunjan , BA
Otolaryngology
Kunjan has been involved in
clinical and basic science
research in genetics,
otolaryngology, and
telemedicine at SLU School
of Medicine and Washington
University School of
Medicine for 6 years. He has
completed multiple clinical
projects working with
Otolaryngology faculty at
SLU School of Medicine.
Obtains consent, Subject
Randomization or
Registry, Collection of
Subject Data, Report Data
(CRFs, e-CRFs,
Spreadsheets), Data
Analysis
 Gresham, Malia, MD
Otolaryngology
Dr. Gresham is an
otolaryngology resident and
is engaged in the study and
treatment of sinonasal
disorders. She has three
years of experience in
clinical research with
projects on topics such as
skull base tumors and
craniofacial trauma.
Recruitment, Obtains
consent, Determine
Subject Eligibility for
Accrual, Subject Physical
Examinations , Follow-up
Visits including physical
assessments, Subject
Randomization or
Registry, Collection of
Subject Data, Report Data
(CRFs, e-CRFs,
Spreadsheets), Data
Analysis
 Cass, Lauren, MD, MPH
Otolaryngology
As an otolaryngology
resident, Dr. Cass is actively
involved with treating
patients with medical and
surgical sinonasal disease.
She has been involved with
medical and clinical
research for eight years as a
medical student and
resident working on various
hospital-based and large
dataset-based projects.
Additionally, she has earned
her Masters in Public Health
with training in biostatistics,
epidemiology, and study
design.
Recruitment, Obtains
consent, Determine
Subject Eligibility for
Accrual, Subject Physical
Examinations , Follow-up
Visits including physical
assessments, Subject
Randomization or
Registry, Collection of
Subject Data, Report Data
(CRFs, e-CRFs,
Spreadsheets), Data
Analysis
 Simpson, Matthew, MPA
Otolaryngology
Matthew has collaborated
with PhD and medical
students, faculty and
physicians to produce a
Data Analysis, Other
(Please insert explanation
below.) Statistician

Page 8 of 43
SLU eIRB
8
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
number of abstracts and
manuscripts for both
publication and delivery at
professional conferences.
 Antisdel, Jastin, MD
Otolaryngology
Dr. Antsidel has 18 years
experience in clinical
research from med school
through a rhinology
fellowship and 8 years in
academic medicine.
 Recruitment, Obtains
consent, Determine
Subject Eligibility for
Accrual, Subject Physical
Examinations, Follow-up
Visits including physical
assessments, Perform
study procedures or
Specimen Collection,
Administer and/or
Dispense Study Drugs,
Biologics or Devices
(must be licensed),
Receive, Store,
Manipulate or Account for
Study Drugs, Biologics or
Devices, Subject
Randomization or
Registry, Collection of
Subject Data, Report Data
(CRFs, e-CRFs,
Spreadsheets), Data
Analysis, Review Adverse
Events, Treat and Classify
Adverse Events
---------------------------------------------------------------------------------------------
* * * Subject Population * * *
 
Subject Population(s) Checklist
 
Select All That Apply :
X
Adults
Cognitively Impaired Subjects
Employees (specifically targeted)
Fetuses
Minors (under 18)
Neonates
Non English Speaking Subjects
Pregnant Women
Prisoners
Students (specifically targeted)
Terminally Ill Subjects
Wards of the State
Other (any population that is not specified above)
       

Page 9 of 43
SLU eIRB
9
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------
* * * Study Location * * *
 
Study Location(s) Checklist
      
Indicate where the study will be conducted. Select all that apply:
Saint Louis University, Medical Center Campus
Saint Louis University, Frost Campus
Saint Louis University, Madrid Campus
X
Saint Louis University, SLUCare Practice Locations
SSM STL (DePaul Hospital, St. Mary's Health Center, St. Joseph (St. Charles, Wentzville, Lake Saint
Louis), St. Clare)
Cardinal Glennon Children's Medical Center
X
Saint Louis University Hospital (SSM Health- SLU Hospital)
SLU-SSM Cancer Center Research Alliance Sites
Other (In the box below, list any off-campus institutions or locations and describe the activities being
conducted there. Please provide letters of cooperation and/or IRB approvals from each location to
document support/approval of the study. You may provide such documentation as it becomes available, but
you may not begin work at those sites until documentation of support is provided to the IRB.)  Please refer
to the  Guidance for involving non-SLU institutions in human subject research.
      
---------------------------------------------------------------------------------------------
* * * General Checklist * * *
 
General Checklist
      
Select All That Apply :
Collection of Specimens
Data collection via e-mail or the Internet
Deception/Incomplete Disclosure
Dietary Supplements, Vitamins, and Other Food Agents
X
FDA Approved Device
X
FDA approved  drugs, reagents, other chemicals administered to subjects (even if they are not being
studied), or biologic products
Genetic Testing
HIV Testing
Human blood, cells, tissues, or body fluids
International Research or Research on International Populations
Investigational drugs, reagents, chemicals, or biologic products
Investigational Device
X
Investigator Initiated Study     *?HELP?*
X
Medical Records
Photography, Video, or Voice-Recording Subjects
X
Questionnaires and/or tests

Page 10 of 43
SLU eIRB
10
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
Radioisotopes/radiation-producing machines, even if standard of care
rDNA/Gene Transfer Therapy
Registry(ies)
Specimens to be stored for future research projects (must be in consent form)
Study of existing data or specimens
X
University Indemnified Study (SLU is responsible for liability coverage)    *?HELP?*
Other (clarify in text box to the right)
Single Use. Provide a brief summary and justification for the Single Use Therapy. Note: This application will
refer to research. For Single Use applications it is understood that 'research' will mean 'therapy'.
       
---------------------------------------------------------------------------------------------
* * * Funding * * *
 
Funding Checklist
 
X
NONE
 
Funding - Grants/Contracts
 
 
Funding - Industry Sponsor
 
 
 
  
  
NOTE:   Applicable grant application, contract or subcontract, investigator's brochure, and sponsor's
protocol (for all industry sponsored clinical trials) must be attached. You will be prompted for these in
section #16 (Attachments).
---------------------------------------------------------------------------------------------
* * * Expedited Paragraphs * * *
To request an Expedited Review, check the appropriate category(ies) below. Provide justification for your request
for Expedited Review.
 
To qualify for expedited review, research activities must (1) present no more than minimal risk to human subjects,
and (2) involve only procedures listed in one or more of the categories below.
 
 
 

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SLU eIRB
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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
1.
Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
 
a) 
Research on drugs for which an investigational new drug application (21 CFR Part 31, 32) is not
required. (Note: Research on marketed drugs that significantly increases the risks or decreases the
acceptability of the risks associated with the use of the product is not eligible for expedited review.)
 
        
    
 b)
Research on medical devices for which
(i) 
An investigational device exemption application (21 CFR Part 812) is not required; or
       
       
       
     
(ii) 
The medical device is cleared/approved for marketing and the medical device is being used in
accordance with its cleared/approved labeling.
 
2.
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
 
a) 
From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts
drawn may not exceed 550 ml in an 8-week period and collection may not occur more frequently
than 2 times per week; or
 
     
     
   
      
From other adults and children, considering the age, weight, and health of the subjects, the
collection procedure, the amount of blood to be collected, and the frequency with which it will be
collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per
kg in an 8-week period and collection may not occur more frequently than 2 times per week.
    
Children are "persons who have not attained the legal age for consent to treatments or
procedures involved in the research, under the applicable law of the jurisdiction in which
the research will be conducted."
 
3.
Prospective collection of biological specimens for research purposes by non-invasive means.
 
  
  
  
EXAMPLES: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or
if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a
need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected
either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric
solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the
membrane prior to or during labor; (h) supra-and subgingival dental plaque and calculus, provided the
collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is
accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by
buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
 
4.
Collection of data through non-invasive procedures (not involving general anesthesia or sedation)
routinely employed in clinical practice, excluding procedures involving X-rays or microwaves. Where
medical devices are employed, they must be cleared/approved for marketing. (Studies intended to
evaluate the safety and effectiveness of the medical device are not generally eligible for expedited
review, including studies of cleared medical devices for new indications.)
 
   EXAMPLES: (a) physical sensors that are applied either to the surface of the body or at a distance and do not

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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
  
  
involve input of significant amounts of energy into the subject or an invasion of the subjects' privacy; (b)
weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography,
electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography,
ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiology; (e) moderate exercise,
muscular strength testing, body composition assessment, and flexibility testing where appropriate given the
age, weight and health of the individual.
 
5.
Research involving materials (data, documents, records, or specimens) that have been collected, or
will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE:
Some research in this category may be exempt from the HHS regulations for the protection of human
subjects. 45CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
 
6.
Collection of data from voice, video, digital, or image recordings made for research purposes.
 
7.
Research on individual or group characteristics or behavior (including, but not limited to, research on
perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and
social behavior) or research employing survey, interview, oral history, focus group, program
evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in
this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR
46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
 
8.
 [FOR IRB use only]. Continuing review of research previously approved by a convened IRB only
when condition (a), (b), or (c) is met.
 
a)
Previously approved research where
(i)
The research is permanently closed to the enrollment of new subjects;
(ii)
All subjects have completed all research-related interventions; and
(iii)
The research remains active only for the long term follow-up of subjects.
 
b)
Previously approved research where no subjects have been enrolled and no additional
risks have been identified.
 
c)
Previously approved research where the remaining research activities are limited to data
analysis.
 
9.
 [FOR IRB use only]. Continuing review or research not conducted under an investigational new drug
application or investigational drug exemption where expedited categories two (2) through eight (8) do
not apply but the IRB  has determined and documented at a convened meeting that the research
involves no greater than minimal risk and no additional risks have been identified.
---------------------------------------------------------------------------------------------
* * * Background, Purpose, Study Procedures * * *
Title
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
 
Complete Sections 1 - 16. In sections that allow reference to sponsor protocol or grant, clearly state section and
page numbers. Any information that is different or specific to the local site should be in the SLU application.
Specify N/A as appropriate.
1. Background
 
     Page numbers from a sponsor's protocol/grant may be referenced in 1a and 1b.
 
  
  
a)  
Provide an introduction and background information. Describe past experimental and/or clinical
findings leading to the formulation of the study, if applicable. Investigator Initiated studies must
cite references in the response provided or attach a bibliography.     *?HELP?*
Endoscopic sinus surgery is commonly used to manage chronic inflammatory frontal sinus
disease that is not adequately controlled with medical therapy alone. In recalcitrant cases, a
more extensive procedure called the modified endoscopic Lothrop procedure or frontal drill-out
(FDO) procedure is often performed [1, 2]. The frontal drill-out procedure is performed
endoscopically and its goal is to create one large common cavity between the left and right
frontal sinuses and nasal cavities to allow adequate drainage and communication for
subsequent drug delivery through sinonasal irrigations if indicated.[3, 4] Failure of this
procedure is most commonly the results of re-stenosis of the outflow tract due to scarring,
adhesions, or progressive disease such as polyposis.[5, 6]  One meta analysis assessing the
long-term complications of frontal drillouts reported an overall failure rate to be 13.9%, defined
as those individuals needing further surgery.[2] Another clinical trial reported a failure rate for a
200-person study to be 30%.[7]
Placing a steroid-eluding biodegradable stent into the sinonasal cavities after surgery is thought
to reduce the occurrence of re-stenosis, both by physically stenting the opening and by treating
resultant inflammation with corticosteroid.[8]  Propel stents are made of synthetic dissolvable
polymer that contains a corticosteroid (mometasone furoate) and has been FDA-approved to
stent and reduce inflammation over 30 days. Similarly, Nasopore is an FDA-approved
fragmentable nasal dressing that is used as a stent. Kenalog soaking the Nasopore is thought
to act as the functional equivalent of the mometasone furoate found in the Propel stent, but this
use is investigational. The effect of stenting and its consequences on the outcomes of FDO
specifically has also not been well studied.[8] Recent randomized-controlled trial of Propel stent
placement after frontal sinusotomy (a less extensive form of frontal sinus surgery compared to
FDO procedure) showed improvement in outcomes compared to no stent placement and no
major complications.[9] There are no known randomized-controlled trials to date of propel stent
placement or Nasopore-soaked kenalog placement after FDO procedure. We wish, therefore,
to perform a randomized trial to compare the efficacy and outcomes of Nasopore-soaked
kenalog versus propel stenting.
1. Gross CW, Harrison SE. The modified Lothrop procedure: indications, results, and
complications. Otolaryngol Clin North Am. 2001;34(1):133-137.
2. Anderson P, Sindwani R. Safety and efficacy of the endoscopic modified Lothrop procedure:
a systematic review and meta-analysis. Laryngoscope. 2009;119(9):1828-1833.
3. Eloy P, Vlaminck S, Jorissen M, et al. Type III frontal sinusotomy: surgical technique,
indications, outcomes, a multi-university retrospective study of 120 cases. B-ENT. 2011;7 Suppl
17:3-13.
4. Weber RK, Hosemann W. Comprehensive review on endonasal endoscopic sinus surgery.
GMS Curr Top Otorhinolaryngol Head Neck Surg. 2015;14:Doc08.
5. Hunter B, Silva S, Youngs R, Saeed A, Varadarajan V. Long-term stenting for chronic frontal

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
5. Hunter B, Silva S, Youngs R, Saeed A, Varadarajan V. Long-term stenting for chronic frontal
sinus disease: case series and literature review. J Laryngol Otol. 2010;124(11):1216-1222.
6. Hoyt WH, 3rd. Endoscopic stenting of nasofrontal communication in frontal sinus disease.
Ear Nose Throat J. 1993;72(9):596-597.
7. Ting JY, Wu A, Metson R. Frontal sinus drillout (modified Lothrop procedure): long-term
results in 204 patients. Laryngoscope. 2014;124(5):1066-1070.
8. Huang Z, Hwang P, Sun Y, Zhou B. Steroid-eluting sinus stents for improving symptoms in
chronic rhinosinusitis patients undergoing functional endoscopic sinus surgery. Cochrane
Database Syst Rev. 2015(6):CD010436.
9. Smith TL, Singh A, Luong A, et al. Randomized controlled trial of a bioabsorbable steroid-
releasing implant in the frontal sinus opening. Laryngoscope. 2016;126(12):2659-2664.
 
Please save frequently
 
  
  
b)  
Describe any animal experimentation and findings leading to the formulation of the study, if
there is no supporting human data.
N/A
 
2. Purpose of the study
 
  
  
a)  
Provide a brief lay summary of the project in <200 words. The lay summary should be readily
understandable to the general public.
Surgery on the frontal sinus is done for patients who have sinus problems that do not respond
to medications. It involves making an opening within the right and left frontal sinus of the nose
to help it drain. For severe frontal sinus disease the sinus is widely opened and the left and
right sinuses become one large sinus. This is done with sharp instruments and rigid
endoscopes placed through the nostrils. While the sinus heals after surgery, a stent or steroids
or both may be used to try to help make sure that the opening does not close back up. Two
current options for this are Propel stents and steroid-soaked Nasopore. Propel stents are FDA-
approved. Nasopore and kenalog injection are both FDA-approved, but their use together is
part of the study and not specifically FDA-approved. A previous study shows that Propel stents
are useful to reduce scarring in other frontal sinus procedures. We would like to know whether
this is true in larger frontal sinus surgery where one common cavity is made and whether both
steroid-containing stents are the same.
 
     Page numbers from a sponsor's protocol/grant may be referenced in 2b and 2c.
 
  
  
b)  
List your research objectives (specific aims & hypotheses of the study).
Aim 1: To compare the difference in mean post-operative SNOT-22 scores between the Propel
stent and Nasopore groups.
Aim 2: To compare the incidence of other surgical postoperative complications (diagnosed
post-operative CSF leak, epistaxis requiring treatment, adhesions) between Propel stent and
Nasopore.
Aim 3: To ascertain the incidence of surgical complications based on the specific frontal sinus

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Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
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pathology
Hypothesis: Patients in the Kenalog-soaked Nasopore group will have outcomes that are non-
inferior compared to the Propel stent group when comparing the long term symptom control as
measured by SNOT-22 scores at 24 months follow-up.
 
Please save frequently
 
  
  
c)  
Describe the study design (e.g., single/double blind, parallel, crossover, control, experimental,
observational, etc.). If the study is investigator-initiated, a timeline for individual subject
recruitment, follow-up, and analysis for the study is required. Also, indicate if the subjects will be
randomized.
Single blind (Subject) randomized, active control study. Subjects will be randomized 1:1  using
the rand function in Microsoft Excel program.
Timeline: There will be a 2 year recruitment period during which patients will be recruited and
eligible to participate. Eligible patients are those with chronic inflammatory sinonasal disease
for whom frontal drill out procedure is indicated after evaluation by otolaryngologist. Patients
eligible for the study and consenting to participate will be randomly assigned to one of two
treatment groups: 1) Nasopore group will receive frontal drill out procedure as indicated with
Kenalog-soaked Nasopore stent applied to the post-operative outflow tract and 2) Propel stent
group will receive frontal drill out procedure as indicated followed by Propel stent placement
applied to the post-operative outflow tract.
After the surgery, we will ask patients to follow up 5 times: post-operatively once between week
1-2, once between week 6-8, month 6, month 12, and month 24. All visits are standard of care.
During those visits, patients will fill out a short research related questionnaire that will ask
about whether or not their symptoms have improved after surgery. We will also assess sinus
cavities with rigid nasal endoscopy. Surgical complications will be documented and SNOT-22
scores will be determined by patients filling out SNOT-22 questionnaire at each visit.
Preliminary analysis will be performed once 5 patients have been enrolled and then every 6
months thereafter until 2 years of follow up of the last subject. We expect enrollment to occur
over a period of 2 years.
 
  
  
d)  
If subjects will be given placebo, please justify placebo use.    *?HELP?*
N/A
 
3. Study Procedures
 
    a)
N
Is this project a multicenter study (i.e., same project is conducted elsewhere by a
different investigator) OR does this study involve conduct of research at multiple sites?
      
Is SLU acting as a coordinating center for other sites OR is the SLU PI a direct recipient
of a federal grant for this research? If yes, complete and attach the  Supplemental
Application for Coordinating Center Activities.
      
Will the SLU site be participating in all parts/procedures/arms of the study?
   
    
    
If No, explain what SLU will NOT participate in:

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
 
Please save frequently
 
Page numbers from a sponsor's protocol/grant may be referenced in 3b, 3c, and 3d.
 
  
  
b)  
Describe all the procedures, from screening through end-of-study, that the human subject must
undergo in the research project, including study visits, drug treatments, randomization and the
procedures that are part of standard of care. Specify which procedures are for research and
which are standard of care. Please note: The box below is for text only. If you would like to add
tables, charts, etc., attach those files in the Attachment section (#16).
Patients who present with chronic inflammatory frontal sinus pathology with indication for frontal
sinus surgery will be evaluated for frontal drill out candidacy per physician judgment and
consented. Once consented, the patients will be randomized 1:1 using the "rand" function
(random number generator) in Microsoft Excel program. Nasopore group will receive frontal drill
out procedure as indicated with Kenalog-soaked Nasopore while the Propel stent group will
receive the Propel Stent after frontal drillout. Lund-McKay CT staging system, a part of the
standard of care, to determine overall and frontal sinus score will be used to help stage and
evaluate patients pre-operatively. A preoperative SNOT-22 score, also done as standard of
care, will be obtained to assess symptom burden. Those who undergo the procedure and have
consented to participate in the study will be asked to present to the otolaryngology clinic for
regularly scheduled follow-up as part of standard of care,where symptoms and complications
will be assessed.  Rigid nasal endoscopy and SNOT-22 score are standard of care for routine
follow-up of patients with chronic inflammatory sinonasal disease and will be performed at each
of the 5 visits: post-operatively 1-2 weeks, 6-8 weeks, month 6, month 12, and month 24. This
data will be abstracted from the records for research purposes. The data collected from the
medical record includes the patient's current ENT-related active medical problems.
Note that to maintain uniformity in care, post-operative antibiotics (defined as up to day 60 post-
op) will only be given to patients in any group if frank purulence is noted intra-operatively. In
addition, in accordance with other trials involving drug eluting stents [1], oral and topic steroids
will not be given to patients in any group until 60 days post-operatively. Because oral steroids
and certain antibiotics have anti-inflammatory properties, this could confound the result of the
study. For this reason, we wish to avoid using them in a random fashion.
1. Forwith KD, Chandra RK, Yun PT, Miller SK, Jampel HD. ADVANCE: a multisite trial of
bioabsorbable steroid-eluting sinus implants. Laryngoscope. 2011;121(11):2473-2480.
 
  
  
c)  
If the proposed study is a clinical trial where a drug, vaccine, device or other treatment is
compared to a placebo group or comparison treatment group, what are the guidelines or
endpoints by which early decisions regarding efficacy or lack of efficacy can be made? For
example, it may be reasonable to stop enrollment on a study when efficacy has already been
clearly demonstrated, to avoid unnecessary enrollments of additional subjects. Alternatively, it
may be reasonable to stop enrollment when it is clear that efficacy will never be demonstrated,
given the statistical power of the study as designed. Describe the guidelines that are in place to
assist in making these determinations, if relevant to the proposed study.
A difference in mean post-operative SNOT-22 score of 9 points will be considered a clinically
significant difference. [1]
 As such, preliminary analyses will be performed once 5 patients have been enrolled and then
every 6 months thereafter until 2 years of follow up of the last subject. If clear statistically
significant inferiority or superiority is demonstrated, the trial will be stopped.
[1] Chowdhury NI, Mace JC, Bodner TE, et al. Investigating the minimal clinically important

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
difference for SNOT-22 symptom domains in surgically managed chronic rhinosinusitis. Int
Forum Allergy Rhinol. 2017;7(12):1149-1155.
 
  
  
d)  
Describe how data analysis will be performed (statistical tests, methods of evaluating data) and
indicate the smallest group/unit for which separate reporting will occur. For studies involving a
questionnaire, if data and reliability information are available, please describe or provide
references. For full board, unfunded studies describe sample size determination and power
analysis. If none, please justify.
The SNOT-22 score assesses symptomatic improvement and burden for patients with
rhinosinusitis and is a clinically validated measure with high internal validity, correlation to its
impact on quality of life, and longitudinal stability after sinus surgery. The minimal clinically
important difference (MCID) for SNOT-22 is 9 points. [1, 2, 3, 4,5]  From historical SLU
otolaryngology practice data, patients who present to the otolaryngology clinic undergoing
sinonasal surgery have a mean SNOT-22 score of 42.0 ± 8.0.
For this randomized, active control study of two types of sinonasal stents with steroid, we are
interested in determining whether the cheaper and more available alternative (Nasopore and
Kenalog) is similar to an accepted treatment (Propel stent) in symptom control at 24 months as
measured by post-operative SNOT-22 scores.
For our sample size determination, we explore the lower limit of a 95% confidence interval (CI)
around the mean difference between post-operative SNOT-22 scores of the two groups. We'll
define the lower limit of the CI, or the margin of inferiority, as -8, which does not include the
predetermined MCID of -9.
We set power = 0.8 and alpha = 0.05.
Given: # subjects in each group = n = [(2(SD)^2) * (z1-(a/2)+z(1-B))^2] / [(u1 - u2)^2]   [ref 6]
SD = 8.0, from SLU historical data
[(z(1-(a/2))+z(1-B))]^2 = 7.8, estimated from z-tables, a = 0.05 and B = 0.2
IF u1 - u2 = -8 then n = 16 subjects
To be conservative in our sample size calculation, we'll use u1 - u2 = -5, which yields a sample
size of 40.
If we assume attrition rate of 10%, we estimate we'll need 45 subjects per group and a total of
90 subjects.
Difference in rates of complications will also be determined by chi-square testing for equality of
proportions between groups. As these outcomes are expected to be few, our target sample size
may not be adequate to determine statistical significance of differences. Reporting these
complication rates nonetheless informs clinical practice.
The smallest group reported will be half of the sample target.
1) Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item
Sinonasal Outcome Test. Clin Otolaryngol. 2009;34(5):447-54.
2) Gray ST, Phillips KM, Hoehle LP, Caradonna DS, Sedaghat AR. The 22-item Sino-Nasal
Outcome Test accurately reflects patient-reported control of chronic rhinosinusitis
symptomatology. International Forum of Allergy & Rhinology. 2017;7(10):945-951.
3) Deconde AS, Mace JC, Alt JA, Rudmik L, Soler ZM, Smith TL. Longitudinal improvement
and stability of the SNOT-22 survey in the evaluation of surgical management for chronic
rhinosinusitis. International Forum of Allergy & Rhinology. 2015;5(3):233-239.
4) Hopkins C, Rudmik L, Lund VJ. The predictive value of the preoperative Sinonasal outcome
test-22 score in patients undergoing endoscopic sinus surgery for chronic rhinosinusitis. The

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Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
Laryngoscope. 2015;125(8):1779-1784.
5) Chowdhury NI, Mace JC, Bodner TE, et al. Investigating the minimal clinically important
difference for SNOT-22 symptom domains in surgically managed chronic rhinosinusitis. Int
Forum Allergy Rhinol. 2017;7(12):1149-1155.
6) Brody T. Clinical Trials. Academic Press; 2016.
 
Please save frequently
 
  
  
e)  
State if deception (including incomplete disclosure of study purpose/procedures) will be used. If
so, describe the nature of the deception and provide a rationale for its use. Also, describe
debriefing procedures or justify a waiver of the requirement to debrief. NOTE: for studies using
deception, an alteration of consent must be justified in the Informed Consent section of the
protocol (#13) and the debriefing script/statement must be uploaded in the Attachments section
(#16).  See IRB Deception Guidelines.
 
    f) 
Is there an accepted standard of care and/or standard practice at SLU for the
condition/disease/situation being studied? This information will assist in comparing
the risk/benefit ratio of study procedures relevant to usual care that would be
received outside of the research context. *?HELP?*
Y
 
    
  
   
If yes, please describe the standard of care and standard practice at SLU for the
condition/disease/situation being studied.
Pre-operative CT scan is standard of care for patients with chronic inflammatory frontal sinus
pathology who are going to undergo surgery.
There is no specific standard of care for follow-up of chronic inflammatory sinonasal pathology
and is left up to the discretion of the attending otolaryngologist. The standard of care for follow-
up of chronic inflammatory sinunasal disease in SLU rhinology practice is what is proposed in
this study (post-op week 1-2, week 6-8, month 6, month 12, month 24, and yearly thereafter).
SNOT-22 questionnaire is standard of care for every patient at every visit in SLU rhinology
practice.
The standard of care for use of Propel stent and nasopore placement as well as topical nasal
steroid at the discretion of the attending surgeon and based on patient's disease process, and
these or a combination of these are routinely used in a large number of patients in a variety of
procedures currently.
Rigid nasal endoscopy is standard of care at all follow-up visits for all patients with chronic
inflammatory sinonasal disease.
As standard of care, patients may receive post-operative oral steroids or antibiotics based on
intra-operative findings or the discretion of the attending surgeon. Strong evidence for or
against use of antibiotics or oral steroids after sinus surgery is not found in the literature and it
is considered an option based on current guidelines.[1]
The only non-standard of care portion of the protocol is placement of Kenalog within Nasopore.
[1] Orlandi RR, Kingdom TT, Hwang PH, et al. International Consensus Statement on Allergy
and Rhinology: Rhinosinusitis. Int Forum Allergy Rhinol. 2016;6 Suppl 1:S22-209.
 
   g) 
Does this study involve any diagnostic imaging, labwork or genetic testing that could
result in clinical discovery (diagnoses, genetic mutations, etc.)? Note that this could
include discovery that is expected (related to the research) or incidental (not related
to research aims, but possible, like a mass/shadow found in imaging despite not
looking for it).
Y
 

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
    
  
   
If yes, please describe and include whether there are plans to share findings with study
participants.
It is possible that CT imaging pre-operatively or rigid nasal endoscopy may discover
unexpected findings (which is true of patients in the study or not in the study since these exams
are standard of care). If this occurs, findings will be communicated to the patient and the proper
treatment/referrals will be recommended/performed.
 
    h) 
Is this study subject to the NIH Genomic Data Sharing Policy?
The NIH GDS policy applies to all NIH-funded research that generates large-scale
human genomic data as well as the use of these data for subsequent research and
includes: genome-wide association studies (GWAS), single nucleotide
polymorphisms (SNP) arrays, and genome sequence, transcriptomic,
metagenomics, epigenomic and gene expression data, irrespective of NIH funding
mechanism. Click here for more specific examples.
N
 
---------------------------------------------------------------------------------------------
* * * Radioisotopes or Radiation Machines * * *
You have not selected the Radioisotopes option in the General Checklist. If you would like to add Radioisotopes
information, please select the option to enable this section.
 
4.  Radioisotopes or Radiation Machines
 
In this section, investigators must enter all radiation usage associated with the protocol.
 
Important: Protocols that involve non-standard of care radioactive materials (which includes the terms
"radioisotopes", "radionuclides", "radiopharmaceuticals", and "nuclear medicine studies", e.g., "PET", "MUGA",
"Zevalin", and/or specific radionuclides such as "F-18", "Tc-99m", "Th-201", "I-131", "Ra-233", "Y-90", etc.) will
receive review by the Radiation Safety Officer (RSO) and/or Radiation Safety Committee (RSC). In these cases,
submission to the RSO/RSC should occur first, even before submission to IRB. For more information on how to
submit for radiation safety review, see RSC  instructions or contact the Radiation Safety Officer at 977-6895.
 
(1) It is the responsibility of the PI to assure the accuracy and completeness of the data submitted in this section,
consistent with guidelines provided below. (2) For projects requiring radiation procedures, please refer to this
guidance.
 
 
a) 
If applicable, list and quantify the radiographic diagnostic and therapeutic procedures associated with
this protocol by clicking "Add" and adding to Table 1 below. (Includes X-ray, fluoroscopy, CT,
radioactive materials, nuclear medicine, PET-CT, radiation oncology, accelerator, Cyber Knife
procedures, etc.)
 
 
b)
 Total estimated research radiation dose * :
 
     
* Calculate from the table above by adding the Effective Dose Subtotals for all procedures.

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Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
 
 
 
NOTE: Informed Consent Radiation Exposure Risk Statement- The applicant must insert the appropriate
Informed Consent Radiation Exposure Risk Statement template language into the SLU IRB Informed Consent,
inclusive of applying the total estimated research radiation dose specified in item b) from the table above, as
instructed in the SLU IRB Informed Consent Template. Contact the IRB Office at 977-7744 or irb@slu.edu with
any questions.
 
 
---------------------------------------------------------------------------------------------
* * * Devices * * *
5. Devices
 
 a) Please list in the space below all investigational devices to be used on subjects during this study.
 
 
 b) Please list in the space below all FDA approved devices to be used on subjects during this study.
 
FDA Approved Devices
Device Name
Manufacturer
Provide IDE #. Documentation
of IDE # required unless
imprinted on sponsor protocol
(attach in section #16).
Nasopore
Stryker
PROPEL Mini Sinus Implant
Intersect ENT
1.
Device Name
Nasopore
2.
Manufacturer
Stryker
3.
Describe the device to be used and attach the device manual in section #16.
From the FDA: Nasopore is a fragmentable nasal dressing and is indicated for use in patients
undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions
between mucosal surfaces; to help control minimal bleeding following surgery or nasal trauma by
tamponade effect and blood absorption. Nasopore is composed of a fragmentable polyurethane that
fragments within several days after insertion in the nasal cavity, whereafter it is drained from the nasal
cavity via the natural mucus flow.
4.
Provide the PMA approval or 510(k) clearance
number or attach letters in section #16.
K052099
5.
Does the research involve use of a commercially
available device for an unapproved purpose?
N
6.
This device research is:Note: Attach
documentation/justification in section #16.
Exempt from IDE regulations, (submit
required attachments)

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Protocol # 28525
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Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
Non-Significant risk, (submit required
attachments)
Significant risk, (submit required
attachments)
The risk determination should be based on the proposed use of a device in an investigation and not on the
device alone.
7.
Provide IDE #. Documentation of IDE # required
unless imprinted on sponsor protocol (attach in
section #16).  See Guidance.
8.
Who holds the IDE? (Could be manufacturer, study
sponsor, or an individual investigator acting as the
'sponsor').
9.
If a SLU Investigator is serving as sponsor-
investigator of the IDE, click Yes to assure that the
additional FDA requirements will be followed.
Yes, the additional FDA requirements will be
followed.
1.
Device Name
PROPEL Mini Sinus Implant
2.
Manufacturer
Intersect ENT
3.
Describe the device to be used and attach the device manual in section #16.
From the FDA SSED: The PROPEL Mini sinus implant is intended for use in adult patients ≥ 18 years
of age following ethmoid / frontal sinus surgery to maintain patency of the ethmoid sinus or frontal
sinus opening. The PROPEL Mini sinus implant separates/dilates surrounding mucosal tissues,
provides stabilization of the middle turbinate, prevents obstruction by adhesions, and reduces
inflammation. The implant reduces the need for post-operative intervention such as surgical adhesion
lysis and/or use of oral steroids.
From the FDA SSED: The PROPEL Mini sinus implant is a bioabsorbable implant designed to
maintain patency of the sinus cavity. The PROPEL Mini implant is manufactured from a synthetic
bioabsorbable copolymer, poly (L-lactide-co-glycolide) (PLG). The implant contains mometasone
furoate (active ingredient), a synthetic corticosteroid with anti-inflammatory activity. Mometasone
furoate is a white to off-white powder. The drug is embedded in a bioabsorbable polymer matrix
containing poly-(DL-lactide-co-glycolide) and polyethylene glycol (inactive ingredients) which provides
for gradual release of the drug.
4.
Provide the PMA approval or 510(k) clearance
number or attach letters in section #16.
P100044/S018
5.
Does the research involve use of a commercially
available device for an unapproved purpose?
N
6.
This device research is:Note: Attach
documentation/justification in section #16.
Exempt from IDE regulations, (submit
required attachments)
Non-Significant risk, (submit required
attachments)
Significant risk, (submit required
attachments)
The risk determination should be based on the proposed use of a device in an investigation and not on the
device alone.
7.
Provide IDE #. Documentation of IDE # required
unless imprinted on sponsor protocol (attach in
section #16).  See Guidance.
8.
Who holds the IDE? (Could be manufacturer, study
sponsor, or an individual investigator acting as the
'sponsor').

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Protocol # 28525
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Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
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9.
If a SLU Investigator is serving as sponsor-
investigator of the IDE, click Yes to assure that the
additional FDA requirements will be followed.
Yes, the additional FDA requirements will be
followed.
---------------------------------------------------------------------------------------------
* * * Drugs, Reagents, Chemicals, or Biologic Products * * *
6. Drugs, Reagents, Chemicals, Biologic Products, or Dietary Supplements, Vitamins, and Other Food Agents
Pilot
Phase I
Phase II
Phase III
Phase IV
X Not Phased
 
List placebo if it is considered a drug (contains more than inactive ingredients). For example, normal saline
is considered a drug that should be listed, whereas placebo tablets are usually inert ingredients that do not
need to be listed.
 
b)
Please list in the space below all investigational drugs, reagents or chemicals to be administered to
subjects during this study. Attach all applicable Investigator Brochures in section #16 (Attachments).
 
 
c)
Please list in the space below all FDA approved drugs, reagents, chemicals to be administered to subjects
during this study. Attach all applicable package inserts in section #16 (Attachments).
 
FDA Approved Drugs, Reagents, Chemicals, Biologic Product
Drug Name
Manufacturer
Source (e.g., Pharmacy,
Sponsor, etc.)
Dosage
Kenalog (Triamcinolone
Acetonide)
Bristol-Myers Squibb
Company
SLU Hospital
40 mg/mL
1.
Drug Name
Kenalog (Triamcinolone Acetonide)
2.
Manufacturer
Bristol-Myers Squibb Company
3.
Source (e.g., Pharmacy, Sponsor, etc.)
SLU Hospital
4.
Dosage
40 mg/mL
5.
Administration Route
Topical (1-2 ml will be used to soak the
packing material)
6.
If not premixed, where will the material be mixed and
by whom?
N/A
7.
Is the drug being used outside of its approved
labeling?
Y
Note: If you selected 'Yes' (to question 7) and an IND# is not provided below, either you must attach
documentation from the FDA in the Attachments section (#16) indicating that one is not required or you
must complete question 11 below, including providing an explanation for no responses.
8.
IND # (if available). Documentation required unless
imprinted on sponsor protocol (attach in section #16).
n/a

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
9.
Name of sponsor or investigator who holds the IND.
(The sponsor could be a drug or device manufacturer
or an individual investigator acting as the 'sponsor'
for the application).
n/a
10.
If a SLU Investigator holds the IND, click yes to
assure that the sponsor-investigator will follow the
additional FDA requirements.
X Yes, the additional FDA requirements will
be followed.
11.
Is the FDA approved drug, biologic or device being
used in this study for a non-FDA approved use
without an IND# or documentation of FDA approval?
Y
11.1. Please note that answering 'YES' to any of the questions below means that submission for request of
an IND is required.
11.2. Is the research being conducted with a commercially
available drug to support a new indication or support
a change in advertising or labeling of the product?
N
11.3. Please explain why the response is “no”, supported
by documentation or information on the drug.
Supporting documentation can be referenced and
attached in the Attachments section (#16).
This is an investigator initiated study which is
not being done to support a change in the
manufacturer's label or support a new
indication
11.4. Does the research use a commercially available drug
that is being administered via a new route or for use
in a different part of the body that may significantly
increase the risk associated with the use of the drug
product?
N
11.5. Please explain why the response is “no”, supported
by documentation or information on the drug.
Supporting documentation can be referenced and
attached in the Attachments section (#16).
Kenalog 40 is specifically approved for
intramuscular or intra-articular use; however,
there is data to support using Kenalog in other
ways, mucosally included.
11.6. Does the research use a commercially available drug
that is being given at a dosage level that may
significantly increase the risk associated with the use
of the drug product?
N
11.7. Please explain why the response is “no”, supported
by documentation or information on the drug.
Supporting documentation can be referenced and
attached in the Attachments section (#16).
The dose being used is 40-80mg  topical
(concentration is 40 mg/ml).
11.8. Does the research use a commercially available drug
that is going to be used in a new patient population
that may significantly increase the risk associated
with the use of the drug product?
N
11.9. Please explain why the response is “no”, supported
by documentation or information on the drug.
Supporting documentation can be referenced and
attached in the Attachments section (#16).
No, in fact we are using the medication so that
systemic effects are not expected.  If anything,
the risk is decreased because of this localized
effect.
 
d)
Please list in the space below all dietary supplements, vitamins, minerals, or foods to be administered to
subjects during this study.
 

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
 
Please read the  IND Statements.
 
---------------------------------------------------------------------------------------------
* * * Other Levels Of Review * * *
7. Other Levels Of Review
 
  
1. University Radiation Safety
  
Protocols that involve non-standard of care radioactive materials (which includes the terms
"radioisotopes", "radionuclides", "radiopharmaceuticals", and "nuclear medicine studies", e.g., "PET",
"MUGA", "Zevalin", and/or specific radionuclides such as "F-18", "Tc-99m", "Th-201", "I-131", "Ra-223",
"Y-90", etc.) will receive review by the Radiation Safety Officer (RSO) and/or Radiation Safety
Committee (RSC). For information on how to submit for radiation safety review, see RSC  instructions or
contact the Radiation Safety Officer at 977-6895.
X
Not Applicable
Yes, study involves radioactive materials (per instructions, submit to RSC before IRB)
 
 
  
2. Institutional Biosafety
  
Experiments involving the deliberate transfer of Recombinant or Synthetic Nucleic Acid Molecules (e.g.,
Gene Transfer), or DNA or RNA derived from Recombinant or Synthetic Nucleic Acid Molecules, or
Microorganisms containing Recombinant or Synthetic Nucleic Acid Molecules and/or infectious agents
(including select agents and toxins as defined by CDC and/or Animal and Plant Health Inspection
Service (APHIS)) into one or more human research participants must be reviewed by the SLU Biological
Safety Officer. Most of these protocols also require review and approval by the SLU Institutional
Biosafety Committee (IBC). Please contact the SLU Biological Safety Officer at 977-6888 for more
information.
X
Not Applicable
Yes, study requires Institutional Biosafety review
 
 
  
3. Pharmacy, Therapeutics, Nutrition, and Transfusion (PTNT) Committee
  
Saint Louis University Hospital requires that all research involving the administration of medications
within the hospital (including outpatient areas such as the Emergency Department, Outpatient Center,
Saint Louis University Hospital-South Campus, etc.) be reviewed and approved by the Pharmacy,
Therapeutics, Nutrition, and Transfusion (PTNT) Committee and that study drugs are received, stored,
prepared, and dispensed by the Hospital's Department of Pharmacy Services. Please contact the
Investigational Drug Services Clinical Pharmacist at 268-7156 or SLUH-IDS@ssmsluh.com for more
information.
X
Not Applicable
Yes, study requires PTNT review
 

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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
 
  
4. Saint Louis University Hospital
  
All research involving Saint Louis University Hospital, including the Emergency Department, inpatient or
outpatient services (including outpatient surgery at ABI and the infusion center at DOB) and medical
record access, requires approval from the Saint Louis University Hospital Research Review Committee
prior to study initiation. This process is designed to facilitate compliance with state and federal
regulations as they pertain to research in hospitals and clinical research billing. Documents should be
submitted as soon as possible, or at the latest, concurrently with IRB submission. Please contact the
Research Compliance Office at 577-8113 or sluh-research@ssmhealth.com of the SLU Clinical Trials
Office (CTO) at 977-6335 or clinical-trials-office@health.slu.edu for more information.
Not Applicable
X
Yes, study requires Saint Louis University Hospital review
 
 
  
5. SSMSL
  
All research involving SSMSL locations (including Cardinal Glennon), including inpatient or outpatient
services and medical record access, requires approval from the SSM STL or SSM Cardinal Glennon
Research Business Review (RBR) prior to study initiation. This process is designed to facilitate
compliance with state and federal regulations as they pertain to research in hospitals and clinical
research billing. While researchers can begin to complete the SSM RBR form at any time, the form
should not be submitted until the IRB and the CTO have approved the study. Please contact the SSMSL
Office at 989-2058 or Marcy.Young@ssmhealth.com for more information.
X
Not Applicable
Yes, study requires RBR review
 
 
6.
&nbspDoes this project require registration on ClinicalTrials.gov, and/or is this project
subject to the NIH GCP Training Requirement? (Select "Yes" if either apply)
Registration may be required if any of the following apply: 1) The project meets the
FDAAA definition of an "Applicable Clinical Trial", which requires registration on
ClinicalTrials.gov. 2) As of January 1, 2017, a new NIH policy mandated biomedical and
behavioral "Clinical Trials" to be registered on ClinicalTrials.gov. In addition, NIH policies
require personnel on NIH "Clinical Trials" to take GCP training every three years. 3)
Registering may be required for Journal Publication (ICMJE). Please review relevant
definitions here. Contact the CTO at clinical-trials-office@slu.edu with questions about
registering on ClinicalTrials.gov and refer to the training page of the IRB website for
information on NIH GCP Training requirements.
Y
 
 
---------------------------------------------------------------------------------------------
* * * Subject Population * * *
8.  Subject Population - In the space below, please detail the participants that you are requesting to recruit
(include description of each group requested)

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
a)
Expected age range of subjects. (For example ≥ 18 yrs to 90 yrs).
Adults ≥18 and ≤90 years of age
 
b)  
Number of evaluable subjects to be accrued at SLU or SLU site (this includes all
sites under the direction of the SLU PI).
90
 
Exceeding the number listed here is a protocol violation. Prior IRB approval is required if additional
participants are to be accrued. If applicable, this number should be consistent with your power analysis
described in 3d.
 
c)  
Number of evaluable subjects to be accrued study wide.  *?HELP?*
90
 
d)
If including vulnerable populations (<a
href=https://www.slu.edu/Documents/research/IRB/Minors_in_Research.doc target=_blank>minors, <a
href=https://www.slu.edu/Documents/research/IRB/Pregnant_Women_Fetuses.docx
target=_blank>pregnant women and fetuses, <a
href=https://www.slu.edu/Documents/research/IRB/Neonates.docx target=_blank>neonates, <a
href=https://www.slu.edu/Documents/research/IRB/Non-English_Speaking_Subjects.doc
target=_blank>non-English speaking, economically or educationally disadvantaged, <a
href=https://www.slu.edu/Documents/research/IRB/Prisoner_Research.doc target=_blank>prisoners, <a
href=https://www.slu.edu/Documents/research/IRB/Adults_Unable_to_Provide_Consent.docx
target=_blank>adults temporarily or permanently unable to consent for themselves): 1) provide the
rationale for the importance of including this population in the research, and 2) specify the measures being
taken to minimize risks to potentially vulnerable subjects. Click on hyperlinks to access <a
href=https://www.slu.edu/division-of-research-administration-home/institutional-review-board-(irb)/general-
guidelines target=_blank>SLU Guidelines containing additional considerations and strategies for mitigating
risks.
N/A
 
e)
If women, minorities, or minors are not included, a clear compelling rationale must be provided unless not
applicable. Examples for not including minors: disease does not occur in children; drug or device would
interfere with normal growth and development; etc. If federally funded reference appropriate section of the
sponsors protocol/grant.  *?HELP?*
Propel stent is not FDA approved for patients under 18 years of age.
 
f) 
If any specifically targeted subjects are students, employees, or laboratory personnel, specify the measures
being taken to minimize the risks and the chance of harm to these potentially vulnerable subjects. See <a
href=https://www.slu.edu/division-of-research-administration-home/institutional-review-board-(irb)/general-
guidelines target=_blank>SLU Guidelines for additional considerations and strategies for mitigating risks.
 
g)
Describe how potential subjects will be identified for recruitment (e.g., chart review, referral from individual's
treating physician, those individuals answering an ad). How will potential participants learn about the
research, and how will they be recruited (e.g., flyer, e-mail, web posting, telephone, etc.)? Upload
recruitment materials in the Attachment Section (#16). Important to remember: potential subjects cannot be
contacted before IRB approval. NOTE: The use of SLU owned websites in an approved SLU format (e.g.,
Cancer Center website, etc.) are always approved methods of recruitment.
Patients who present with frontal sinus pathology and are candidates for frontal sinus surgery will be
evaluated for Frontal Drill out candidacy per physician judgment and consented. Lund-McKay CT staging

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
system to determine overall and frontal sinus score will be used to help stage and evaluate patients.
Once patients are identified, they will be recruited in person and consented.The physician or a study team
member will explain orally the benefits, risks, and nature of the intervention using the predetermined script.
Patients will have the chance to ask questions directly. They will be asked whether they are interested
participating in the study. The patient will have the ability to opt out of the trial at any time, with no impact
on their care or treatment. In person, the patient will be able to consent via signature on the attached
consenting document.
---------------------------------------------------------------------------------------------
* * * Subject Population * * *
8. Subject Population (continued)
Page numbers from a sponsor's protocol/grant may be referenced in 8h.
 
h)
Inclusion and Exclusion Criteria.
 
 
  
Identify inclusion criteria.
Adults ≥18 and ≤90 years of age
Patients able to speak and understand English.
Patients for whom frontal drill out procedure is medically indicated as judged by attending physician
surgeon.
 
 
  
Identify exclusion criteria.
Patients who are cognitively impaired and unable to consent.
Patients who are not candidates for Frontal Drill out, whose frontal sinus pathology is responsive to
medical therapy alone, or present with other comorbidities that makes them poor candidates for the
procedure
Patients with contraindications to PROPEL Mini sinus implant or Kenalog soaked nasopore: Patients
with a known hypersensitivity to mometasone furoate, Kenalog, lactide, glycolide or caprolactone
copolymers.
Non-English speaking patients.
 
i)
Compensation. Explain the amount and schedule of compensation, if any, that will be paid for participation
in the study. Include provisions for prorating payment.
There will be no compensation paid for participation in the study.
 
j)
Describe who will cover study related costs. Explain any costs that will be charged to the subject.
All procedures are standard of care; no additional research related costs will be incurred. Insurance will be
billed for the standard of care procedure. Any administrative costs will be covered by the Otolaryngology
department.
 
k)
Estimate the probable duration of the entire study including data analysis and publication. This estimate
should include the total time each subject is to be involved and the duration the data about the subject is to
be collected. If the study is  Investigator-initiated, a timeline  for individual subject recruitment, follow-up,
total time for subject accrual, and data analysis for the study is required.
The total length of study can be up to 4 years from enrollment to completion. Recruitment will take place
over a two year time period. The total timeline of subject involvement will be 2 years (follow-up visit

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
schedule previously described). Preliminary analysis will occur once 5 patients have been enrolled and
then every 6 months thereafter.  Data analysis and publication of data after all follow-ups are completed
will take approximately one year after completion of follow-up. Each subject, after consenting and
undergoing the procedure, will be then followed for two years, which is when post-operative data will be
collected. Pre-operative data will be obtained at the time of consent.
 
---------------------------------------------------------------------------------------------
* * * Risks * * *
9. Risks
     
There is no research that can be considered totally risk free (e.g., a potential risk of breach of
confidentiality). Therefore, when describing the risk, the lowest level of risk is "no more than minimal risk".
 
 
Page numbers from a sponsor's protocol/grant may be referenced in 9.1, 9.2, 9.3, and 9.4.
 
 
 
 
    1.
Use of investigational devices. Please include the clinical adverse events (AEs) associated with each
of the devices with an indication of frequency, severity and reversibility. This information can often be
found in the Investigator(s) brochure. NOTE: Include any likely adverse effects associated with
procedures that subjects may experience while in the study.
 
 
 
 
 
    2.
Use of investigational drugs. Please include the clinical AEs associated with each of the drugs with an
indication of frequency, severity and reversibility. This information can often be found in the
Investigator(s) brochure. NOTE: Include any likely adverse effects associated with placebos or
washout periods that subjects may experience while in the study.
 
 
 
 
 
    3.
Use of FDA approved drugs, reagents, chemicals, or biologic products.  Please include the clinical AEs
associated with each of the drugs with an indication of frequency, severity and reversibility. This
information can often be found in the package insert provided by the manufacturer. NOTE: Include any
likely adverse effects associated with placebos or washout periods that subjects may experience while
in the study.
From the FDA-warning regarding Kenalog: The following adverse reactions may be associated with
corticosteroid therapy:
Allergic reactions: Anaphylactoid reaction, anaphylaxis including anaphylactic reactions
and anaphylactic shock, angioedema. "In clinical trials, common adverse effects for triamcinolone
acetonide include sneezing, dry, mucosa, nasal irritation, sinus discomfort, throat discomfort, epistaxis
and headache." [1] These are imminently preventable as corticosteroids are used commonly, so
patients generally have a history of reaction to them.
Additional risk of complications for the Nasopore group include forming adhesions, scarring caused by
surfaces of the nose healing together to cause a scar,   in the nose.
•Possible allergic reactions: severe allergic reaction with shortness of breath • throat or mouth swelling
•Formation of bands of scar tissue (synechiae) is a risk of sinus surgery and covered in your surgery
consent. In one study, 4% of patients had scar band present 3 months after surgery. The use of the
Nasopore is to try to decrease scar formation. However, there is still a small risk of scarring with the
Nasopore material used in the sinuses. The impact of scarring may not be significant and not need

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
treatment; however, it may require having the scarring cut in clinic during rigid nasal endoscopy, or if
very extensive, could rarely result in return to the operating room
•Common adverse effects for triamcinolone acetonide include sneezing • dry mucosa, nasal irritation •
sinus discomfort • throat discomfort • nose bleeds • headache • burning, itching, irritation, dryness,
blistering or peeling not present prior to therapy • perioral dermatitis • allergic contact dermatitis •
maceration of the oral mucosa • secondary infection and thinning of the oral mucosa.
These are imminently preventable as corticosteroids are used commonly, so patients generally have a
history of reaction to them.
Additional risk of complications for the Propel stent group include developing headaches, ear
infections and nausea after surgery. These complications are not severe and are medically treatable in
most cases.
Potential adverse effects associated with the PROPEL sinus implant are anticipated to be similar to
those associated with other sinus stents, gels or packing. Below is a list of the potential adverse
effects (e.g., complications) associated with the use of the device.
•Potential adverse effects associated with the PROPEL Mini sinus implant include, but may not be
limited to: • premature displacement of implant or small implant fragments out the nares • swallowing
implant or implant fragments • adherence of crusting to implant, resulting in, or contributing to
sensations of pain/pressure/headache • aspiration of small implant fragments (not observed in clinical
trials) • foreign body response, including formation of granulation tissue.
•Potential risks or side effects associated with intranasal mometasone furoate include: • nasal irritation
• hypersensitivity reaction • intranasal bleeding • localized infection (bacterial, fungal or viral) in the
nose or pharynx • nasal burning • nasal dryness • susceptibility to secondary infections due to
bacteria, fungi or viruses • glaucoma/elevation of intraocular pressure • cataracts/change in lens
opacities • headache • pharyngitis.
•Potential risks or general side effects associated with steroids: • hypersensitivity reactions • headache
• nose bleeds • coughing • vomiting • fungal infection• glaucoma/elevation in eye pressure •
cataracts/changes in lens opacities • joint and muscle pain.
Note that a lot of these AEs are extremely rare (<1%) - see attached document. Corticosteroids are
pervasively used in Otolaryngology as well as the field of medicine, and the doses used here are
unlikely to result in significant AE's, especially as corticosteroids are commonly used after surgery in
order to prevent complications.
[1] Gawchik SM1, Saccar CL. A risk-benefit assessment of intranasal triamcinolone acetonide in
allergic rhinitis. Drug Saf. 2000 Oct;23(4):309-22.
 
 
 
 
 
    4.
Use of FDA approved devices. Please include the clinical adverse events (AEs) associated with each
of the devices with an indication of frequency, severity and reversibility. This information can often be
found in the Investigator(s) brochure. NOTE: Include any likely adverse effects associated with
procedures that subjects may experience while in the study.
Based on clinical trials and FDA's SSED, the adverse event rate for Propel stent is as follows (see
attached document): Acute sinusitis (15.0%), Chronic sinusitis (11.3%), Headache (11.3%), Upper
respiratory tract infection (6.3%), Presyncope (5.0%), Epistaxis (5.0%), Otitis media acute (3.8%),
Asthma (3.8%), Nasal congestion (3.8%), Eyelid edema (2.5%), Nausea (2.5%), Influenza (2.5%),
Nasopharyngitis (2.5%), Nasal polyps (2.5%). All of these events are not severe and treatable.
The AEs associated with Nasopore include formation (see attached document) of adhesions (10.5%),
inflammation of nasal mucosa (<5%), post-operative bleeding (2%), and sinus infection (4%). All of
these events are not severe and treatable.
 
 
      5.
Describe any risks related to performing study procedures. Please include all investigational, non-

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
 
 
investigational, and non-invasive procedures (e.g., surgery, blood draws, treadmill tests).
There are no aspects of this study that involve risk of harm or discomfort greater than
ordinarily encountered in the standard course of the participants' medical treatment in patients for
whom frontal drill out is indicated regardless of study participation. Frontal drillout complications may
include epistaxis, orbital/periorbital ecchymoses and emphysema, dental pain, adhesions, hyposmia,
and stenosis, meningitis and brain abscess and intraoperative trauma. Intraoperative trauma may
cause CSF leaks, intraorbital hemorrhage, diplopia, blindness, epiphora, intracranial injury, stroke,
tension pneumocephalus, significant epistaxis, and anosmia. There is always the risk of developing
previously unknown side effects. Patients may encounter these risks regardless of participation in this
research study. The investigator is willing to discuss any questions the participant may have about
these risks and discomforts.
 
 
 
 
 
    6.
Describe any risks related to the use of radioisotopes/radiation-producing machines (e.g., X-rays, CT
scans, fluoroscopy).
 
 
 
 
 
    7.
Describe why this investigational compound/drug/device/procedure's risks/benefits are potentially
better than standard of care or other common alternatives. Any standard treatment that is being
withheld must be disclosed and the information must be included in the consent form. *?HELP?*
No standard treatment is being withheld. We are attempting to determine which device used in the
standard of care is more beneficial than the alternative.
 
 
 
 
 
    8.
Describe any psychological, social, or legal risks the subject may experience.   *?HELP?*
Breach of Confidentiality
Information will be kept under lock and key with password protection on the computer. Coding will be
used with no patient identifiers attached to confidential information. Even with these precautions,
breach of confidentiality is a risk.
Use of Questionnaires:
Some questions in the questionnaires may make subjects feel uncomfortable. Subjects may choose
not to answer any question with which he/she feels uncomfortable.
 
Page numbers from a sponsor's protocol/grant may be referenced in 9.9 and 9.10.
 
 
 
 
  
9.
Special Precautions. Describe the planned procedures for protecting against or minimizing potential
risks. If appropriate, include the standards for termination of the participation of the individual subject.
Discuss plans for ensuring necessary medical or professional intervention in the event of adverse
effects to the subjects.
Patients may opt out at any time without penalty. Regular postoperative follow-up to assess any
complications from the procedure will minimize potential risk. In case of adverse event or complication
from the procedure discussed above, clinician judgment and follow-up will ensure necessary medical
intervention.

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
Use of questionnaire: Subjects may choose not to answer any question with which he/she feels
uncomfortable
 
 
 
 
  
10.
Reproductive Risks.
 
 
 
    
   
a.
Please list the pregnancy category of any drugs or N/A.
Kenalog Pregnancy Category: C
 
           b. Please describe any reproductive risk associated with any part of the research study. Include any data
from other studies (animal or human).
The frontal drill out procedure and steroids used are topical, so they do not have systemic effects.
Thus, reproductive risk is not associated with any part of the research study.
 
11.
Data Safety Monitoring
 
 
 
 
          
Federal regulations require that when appropriate, the research protocol makes adequate provisions
for monitoring the data to ensure the safety of participants. Monitoring should be commensurate with
risks and with the size and complexity of the research, and could range from no plan needed to an
independent data safety monitoring board. Please refer to  SLU Guidelines for Data and Safety
Monitoring as you complete the questions below.
 
a.
Is there a Data Monitoring Committee (DMC) or Board (DSMB)?
N/A
 
 
 
 
 
          
If yes, please provide the following information (labeled a-g): a)  the composition of the board
(degrees/qualifications of members),  b)  whether the board is independent from the sponsor and
research team or not,  c)  frequency of meetings and issuance of reports to sites,  d)  assurance that
the board is reviewing aggregate safety data and making recommendations regarding study
continuance,  e)  provisions for ad hoc meetings if needed,  f)  who is reviewing SAEs in real time (MD
or DO), and  g)  stopping/halting rules (if any exist).
A DSM charter can be referenced for all items except for "f) who is reviewing SAEs in real time."
 
 
 
 
 
          
If no, please justify why not.
 
     
b.
  Is there a Data Safety Monitoring Plan (DSMP)?
Y
 
 
 
 
 
          
Note, if all relevant plan information is included in DSMB question above, select 'Yes' and state "see
above" in the answer box.

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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
 
 
 
 
 
          
If yes, provide details (labeled a-e) including: a) what types of data or events are captured and how are
they documented, b)  who is monitoring data, their independence/affiliation with the research and their
degrees/qualifications, c)  frequency of aggregate data review, d)  who is reviewing SAEs in real time
(MD or DO), and  e)  stopping/halting rules (if any exist).
a) The types of data and events are that are captured are included in the data collection sheet. In
short, they include responses to questionnaires, procedural data (sinus patent or not) from the rigid
endoscopy, CT scan evaluation, and a patient's past medical history (ENT related). The data will be
found in the electronic medical record (EPIC) and the data collection sheet. With the exception of the
data collection sheet and the consent form, no PHI will be documented anywhere besides EPIC.
Protocols are in place to ensure that they are safe (see section 11 of the protocol).
b) The data will be monitored by Dr. Brunworth (MD, Assistant Professor of SLU Department of
Otolaryngology), who is the PI of the study.
c) The aggregate data will be formally reviewed once every 10 patients have completed follow up.
d) Dr. Brunworth will be reviewing SAEs in real time as he is the only faculty (at SLU or otherwise)
who will be involved in the study. We don’t expect the AE frequency, type and severity to be
significantly different between the Kenalog and Nasopore groups as the treatment options are quite
similar. This is because the surgical technique (i.e. the frontal drill-out) is identical - the only difference
is the type of stent (both of which have steroids), and the AE profile of both interventions is similar and
treatable (see section 9, subpoint 4). Regardless, we are planning to record and review the AE
number and type (major, minor) every after the first 5 patients have enrolled and then every then every
6 months thereafter until 2 years of follow up of the last subject.
e) n/a
 
 
 
 
 
          
If no, please justify why not.
 
   
12.
In case of international research (research outside of the U.S. or research on international
populations (non-U.S.)), describe qualifications/preparations that enable you to evaluate cultural
appropriateness and estimate/minimize risks to subjects. Include whether research is sensitive given
cultural norms.
 
 
 
 
    a.
State any local laws/regulations governing Human Subjects Research in the country(ies) you will
conduct the research and attach any relevant approvals. If none, state N/A.
 
 
 
 
    b.
Will there be language barriers and if so, how will they be addressed?
 Note: If materials are to be distributed to subjects in their native language, please follow  SLU's
Guidance For Studies Involving Non-English Speaking Subjects.
 
          NOTE: Export control laws include the transfer of technical information and data, as well as information
and technology to foreign nationals. If this study has international components, contact the  SLU Export
Control Officer for direction on whether export control policies apply.
 
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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
* * * Benefits/Alternatives, Procedures to Maintain Confidentiality and Privacy * * *
10. Benefits/Alternatives
a)
Benefits. Describe the potential benefit(s) to be gained by the subjects and how the results of the study
may benefit future subjects and/or society in general.  Indicate if there is no direct benefit to the
participants.
a.) Subjects will not benefit from the research.
b.) Society may benefit from research findings because they will provide physicians with evidence of the
effectiveness of the two devices and help them make well educated decisions about which device is best
in practice
 
b)
Alternatives. Describe any alternative treatments and procedures available to the subjects should they
choose not to participate in the study. If no such alternatives exist, please state that the alternative is
nonparticipation. For some studies, such as record reviews, a description of alternatives would not be
applicable.
The alternative is non-participation in the study. The patient will still undergo your sinus surgery as planned
and receive one of the two stents described in this study, Propel or Nasopore, as determined by Dr.
Brunworth.
 
11. Procedures to Maintain Confidentiality and Privacy
        
Federal regulations require that research materials be kept for a minimum of three (3) years and HIPAA
documents be kept for a minimum of six (6) years after the closure of the study. For FDA-regulated or
sponsored projects, the PI may be required to keep the data and documents for a longer time period.
 
Confidentiality
 
         To determine whether adequate provisions for confidentiality of data are in place, the IRB must ensure that
research materials are stored in appropriate locations throughout the study (during collection,
transport/transmission, analysis and long term storage). Research information must be protected using
appropriate safeguards based on identifiability of the data and risk associated with the study (See SLU IRB
Confidentiality Guidelines).
     
For the questions below, please use the following definitions:
&nbsp&nbsp&nbsp&nbsp&nbspAnonymous/De-identified: data contain no identifiers, including code
numbers that investigators can link to &nbsp&nbsp&nbsp&nbsp&nbspindividual identities;
&nbsp&nbsp&nbsp&nbsp&nbspCoded: data in which (1) identifying information, such as name or social
security number, has been replaced &nbsp&nbsp&nbsp&nbsp&nbspwith a number, letter, symbol, or
combination thereof (i.e., the code), and (2) a key to decipher the code exists
&nbsp&nbsp&nbsp&nbsp&nbspenabling linkage of data to identifying information (e.g., a master list), and
(3) the key (master list) is kept &nbsp&nbsp&nbsp&nbsp&nbspseparately from coded data; AND/OR
&nbsp&nbsp&nbsp&nbsp&nbspIdentifiable: data that includes personal identifiers (e.g., name, social
security number), such that &nbsp&nbsp&nbsp&nbsp&nbspinformation could be readily connected to
respective individuals.
 
 
a)
Electronic (Computer) Data

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
 
     
Click "Add" to enter data security information for each type of electronic data that will be created in the
study: anonymous/de-identified, coded, and/or identifiable (see definitions above).
 To properly address this question, there should only be one listing of each type of data in the table.
Depending on your project, you could have up to three types of data. See the SLU ITS Sensitive Data Guide
for acceptable data security methods.
 
Not Applicable, No Electronic (Computer) Data
Study IRB-approved Prior to New Question (Question N/A- Grandfathered)
 
Electronic Data
Type of Data
Storage Location
Data Transmission
Outside of SLU
Supplemental information
related to above items
can be entered here or
leave blank:
Coded
SLU Google
Drive/Documents
Not Applicable, I will not
be sending/sharing
electronic data outside of
SLU
1. What type of electronic (computer) data does your study involve? Note: only one data type can be
selected. Click on Add from the main page to enter information for additional data types once you've
saved this information.
 
Anonymous/De-identified
 
X
 Coded
 
Identifiable
2.
Where are the data being kept/collected? (Check all that apply)
NOTE: THE ITEMS LISTED BELOW IN ITALICS CANNOT BE USED FOR DATA WHICH ARE (1)
SENSITIVE AND CODED OR (2) IDENTIFIABLE unless an exception has been granted by the SLU
Info Security Team (InfoSecurityTeam@slu.edu). Please attach proof of exception in section #16.
 
SLU ITS managed device (computer, tablet, etc.) with encryption
 
SLU ITS managed device (computer, tablet, etc.) without encryption
 
SLU ITS network storage (T: drive (shared drive), U: drive (personal drive))
 
SLU ITS recognized document-level encryption
 
X
SLU Google Drive/Documents (can only be shared with slu.edu addresses)
 
Collection or Storage of data in SLU REDCap
 
Collection or Storage of data in SLU Qualtrics
 
Removable storage devices (flash drive, USB hard drive) with encryption
 
Removable storage devices (flash drive, USB hard drive) without encryption

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
 
Personally owned/non-SLU managed device (computers, tablets) with encryption
 
Personally owned/non-SLU managed device (computers, tablets) without encryption
 
Third party services such as Dropbox, Box, Evernote, SurveyMonkey,
etc. (Please specify):
 
Sponsor provided system or portal (Please specify):
 
Other (Please specify):
3. If the data will be sent/shared outside of SLU, how are they being sent/shared? (Check all that apply)
 
X
Not Applicable, I will not be sending/sharing electronic data outside of SLU
 
SLU Email account with an encrypted file attachment
 
Posting of data directly to an external web portal using secure connection (i.e., HTTPS)
 
Sending of data to a secure FTP site (e.g., SFTP, FTPS)
 
Use of Virtual Private Network connection (VPN)
 
Use of SLU REDCap account
 
Use of an external Secure Web Mail account
 
Physical delivery of encrypted files via CD/DVD or other medium (e.g., USPS, FedEx, Courier)
 
Other (Please specify):
4. Supplemental information related to above items can be entered here or leave blank:
 
b)
Hardcopy (Paper) Data
 
     
Click "Add" to enter information for each type of hardcopy (paper) data that will be created in the study:
anonymous/de-identified, coded, and/or identifiable (see definitions above).
 To properly address this question, there should only be one listing of each type of data in the table.
Depending on your project, you could have up to three types of data.
 
Not Applicable, No Hardcopy (Paper) Data
Study IRB-approved Prior to New Question (Question N/A- Grandfathered)
 
Hardcopy Data
Type of Data
Storage Location
Transported Data
Security
Supplemental information
related to above items
can be entered here or
leave blank:
Identifiable
SLU Locked Cabinet;
SLU Locked Suite
Personnel Supervision
1. What type of hardcopy (paper) data does your study involve? Note: only one data type can be selected.
Click on Add from the main page to enter information for additional data types once you've saved this
information.

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
 
Anonymous/De-identified
 
 Coded
 
X
Identifiable
2. Where are hardcopy materials being kept? (Check all that apply)
 
X
SLU Locked Cabinet
 
SLU Locked Room/Office
 
X
SLU Locked Suite
 
SLU Long Term Storage Facility
 
Non-SLU Location (Please specify):
 
Other (Please specify):
3. If hardcopy materials are transported at any time in the study (e.g., from data collection site to storage
site, shared with co-investigators), how are they secured?
 
Locked container
 
X
Personnel Supervision
 
Physical delivery (e.g., USPS, FedEx, Courier)
 
Fax Machine
 
SLU Email account with an encrypted file attachment
 
Non- SLU Email account with an encrypted file attachment
 
Other (Please specify):
4. Supplemental information related to above items can be entered here or leave blank:
 
 
c)
If a master list is used in this study (linking study codes to subject identifiers), explain: a) how and where
you will secure the master list, b) how long it will be kept/when it will be destroyed, and c) provide a sample
of the code.
A master list linking each patient with code will be kept on a separate spreadsheet. The data will be stored
on a SLU ITS managed device.until the end of the study and completion of the manuscript, approximately
November 2021, when it will be disposed of by electronic deletion. It will be password protected by SLU’s
secure network domain. In addition, the computers will be username and password protected by SLU’s
domain. No data will be downloaded or stored on local or private hard drives or flash drives. Only study
team members will have access to the data.
The code will be numeric (1, 2, 3, 4....).
 
d)
If data or specimens are being shared outside of the research team, indicate who will receive the material,
specifically what they will receive (data or specimens), and if an agreement has been signed to cover the
transfer. Note: unless covered under a Clinical Trial or other agreement, the transfer of data or specimens
to an external entity will require an agreement. For the transfer of materials (specimens), a Materials
Transfer Agreement (MTA) is used; for the transfer of data, a Data Use or Data Transfer Agreement is
used. Please contact the Research Innovation Group at 314-925-3027 for assistance.
N/A
 
 
e)
If samples or data will be provided to SLU from an outside source, indicate whether you will  have access

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
to identifiers, and if so, how identifiable information is protected. Note: unless covered under another
agreement (e.g., Clinical Trial Agreement or subcontract), the transfer of data or specimens from an
external entity to SLU may require an agreement. For the transfer of materials (specimens), a Materials
Transfer Agreement (MTA) may be required; for the transfer of data, a Data Use or Data Transfer
Agreement may be required. Please contact the Research Innovation Group at 314-925-3027 for
assistance.
N/A
 
f)
If data will be collected via e-mail or the Internet, how will anonymity or confidentiality be affected?
Describe how  data will be recorded (i.e., will internet protocol (IP) addresses and/or e-mail addresses be
removed from data?).
 
g)
If you will be audio/video recording or photographing subjects, provide a rationale as voiceprints and
images of faces/unique body markings are considered identifiers.  Describe confidentiality procedures,
including any restricted access to images and/or the final disposition of the recordings/photos (destruction,
archiving, etc.).
 
h)
Describe any study-specific (non standard of care) information or documentation that will be put in the
participants' medical records for this research (e.g., study visit notes, lab results, etc.). If none, state "not
applicable". NOTE: documentation of research in Epic should be done in accordance with the <a
href=https://www.slu.edu/Documents/research/IRB/Epic_Research_Charting_Policy.pdf
target=_blank>SLUCare Epic Research Charting Policy and <a
href=https://www.slu.edu/Documents/research/IRB/Reasearch_Documentation_Epic.pdf
target=_blank>Clinical Workflow: Documenting Research Encounters in Epic.
N/A
 
i)
Are there any information security requirements identified in the project's RFP/Award
Notice/Contract? This could include data security, technical safeguards, security
controls, NIST, FISMA, CFR, etc.
 If yes, SLU ITS approval is required. Contact InfoSecurityTeam@slu.edu to start the
approval process.
N
 
Priv
acy
 
 
Privacy refers to persons having control over the sharing of oneself with others.
 
j)   Please indicate how participant privacy will be protected in this study (select all that apply):
 
X
Discussion of health related and/or personal information in a private room/area
 
X
Research interactions/interventions are conducted in a private room/area
 
X
Use of drapes or other privacy measures

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
 
X
Collection of sensitive/identifiable information is limited to the minimum necessary to achieve
the aims of the research
 
X
Access to study information is limited to the minimum amount of persons necessary to achieve
the aims of the research (e.g., access restricted to research team members only)
 
Consideration of parental inclusion/absence for studies involving minors
 
Other (please explain):
       
 
 
---------------------------------------------------------------------------------------------
* * * Potential Conflict of Interest * * *
12. Potential Conflict of Interest
  
    
Indicate whether you, your spouse or dependent children,  have, or anticipate having, any income
from or financial interest in a sponsor, device or drug manufacturer of this protocol, or a company
that owns/licenses the technology being studied. Please remember that you are responding for you
and any other investigator participating in the study. Financial Interest includes but is not limited to:
consulting; speaking or other fees; honoraria; gifts; licensing revenues; equity interests (including
stock, stock options, warrants, partnership and other equitable ownership interests). For questions
regarding Conflict of Interest consult the  Conflict of Interest in Research Policy.
 
Check one of the following (please remember that you are responding for yourself, your spouse, dependent
children and any investigator, investigator's spouse and dependent children participating in the study):
 
1)
X
No equity interest and/or Financial Interest less than or equal to $5K
2)
Any equity interest and/or Financial Interest  exceeding $5K but not exceeding $25K in the past
year or expected in the current year
3)
Financial Interest  exceeding $25K in the past year or expected in the current year
 
Check all those that apply:
 
         
Consulting
         
Speaking Fees or Honoraria
         
Gifts
         
Licensing agreement or royalty income
         
Equity interests, (including stock, stock options, warrants, partnership or equitable ownership
interests), or serving on a scientific advisory board or board of directors
         
Other fees/compensation
 
 

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
       
If you have marked #2 or #3, please contact coi@slu.edu to initiate review of this study and provide the
following information:
 
1. 
A Conflict of Interest Management Plan.
            
has been approved for all investigators for this study
            
is pending
            
has not been initiated
 
2. 
Describe who has, and briefly explain, the conflict of interest and indicate specific amounts for
each subcategory checked:
      
 
  Note to Investigator(s) Reporting a Potential Conflict of Interest
 
  Investigator(s) must have:
 
1.
Current, up-to-date Conflict of Interest Disclosure Form  on file with the SLU Conflict of Interest
in Research Committee (COIRC) that describes any financial relationship indicated above.
 
                  
.
This information must be disclosed on the SLU confidential Conflict of Interest
Disclosure Form and reviewed by the COIRC before accruing research subjects in this
study. If your current Disclosure Form does not contain this information, you are
required to submit an updated Disclosure Form to the COIRC.
 
2.
You may not begin your study until your disclosure form has been reviewed and any required
management plan has been approved by the COIRC for this study. To initiate COIRC review of
your study, please contact coi@slu.edu.
---------------------------------------------------------------------------------------------
* * * Informed Consent * * *
13. Informed Consent
 
Federal regulations require that informed consent be obtained from individuals prior to their participation in
research unless the IRB grants a waiver of consent. Answer the questions, below, then click Add to provide
the necessary consent documents and information regarding subject consent. Multiple consents/waivers
may be added, but they must be uploaded one at a time.
 
NOTE: You may refer to the SLU IRB Guidance for Obtaining Informed Consent for considerations
regarding the consent/assent process.
 
State N/A if not applicable.
 
  
  1)
How is consent being obtained? When and where will the discussion take place? If the study involves
a Non-English Speaking participant/population, please include details about plans for translated

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
consent materials and interpreters to be used (see <a
href=https://www.slu.edu/Documents/research/IRB/Non-English_Speaking_Subjects.doc
target=_blank>SLU Guidelines for Involving Non-English Speaking Subjects for more details).
Patients who present in clinic with chronic inflammatory frontal sinus pathology with indication for
frontal sinus surgery will be evaluated for frontal drill out candidacy per physician judgment and
consented. Informed consent will be sought from the patient at this out-patient visit prior to their
procedure. The patients will have no limit on time to consent. The PI or study team member will
initially discuss the study with the potential subject, including the risks, benefits, and alternatives.
The subject will be provided with information about the study and their role. They will be informed
that they may terminate their participation at any time for any reason. If they agree to participate,
consent will be signed at that time.
 
  
  2)
If the study involves adults unable to consent for themselves (whether diminished capacity to consent
is temporary, permanent, progressive or fluctuating), please address the following: a) how is capacity
to provide consent being assessed (initially and throughout study, if applicable); b) if unable to
provide consent, how is LAR being determined (See <a
href=https://www.slu.edu/Documents/research/IRB/LAR_Guidelines.docx target=_blank>SLU LAR
Guidelines); c) if unable to provide consent, will assent be obtained and if not, why not?; d) if unable
to provide assent, will dissent be honored and if not, why not? Note: participants initially unable to
provide consent for themselves are expected to be given an opportunity to provide consent once
capacity is gained. See <a
href=https://www.slu.edu/Documents/research/IRB/Adults_Unable_to_Provide_Consent.docx
target=_blank>SLU Guidelines for Adults Unable to Provide Consent for additional detail.
N/A
Note: Any assent documents which will be used per the Adults Unable to Provide Consent guidance, should be
appropriately named and uploaded using the Add button and the Consent drop down menu selection.
 
Informed Consent
Title
Consent Type
Attached Date
Approved_Consent version 4
Consent
04/05/2018
  Title
Approved_Consent version 4
  Consent Type
Consent
Upload Consent Form/Document
X Attachment 
Approved_Consent version 4
Upload your informed consent document. Use the SLU Informed Consent Template to create your consent
document. If more than one consent will be used (e.g., adult consent, parental consent, etc.), label the
consent documents with these headings to help distinguish them from one another.
 Upload any assent documents which will be used for adults who are unable to provide consent here and
not in the assent section.
Address the following question. A Yes/No response is not adequate.

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------
* * * Assent * * *
14. Assent
     
Complete this section if your study includes minors. The Assent Form Template provides
guidelines for writing assent documents.
 
     
 1.
Will minors be asked to give assent, then consent once they reach adulthood? If not, please justify. If
not capable to provide assent initially, please address whether assent will be obtained as the minor
gains capacity. Note: children who reach the age of adulthood during participation should be given
the opportunity to provide consent as parent/guardian consent no longer applies. If obtaining consent
would be impracticable (e.g., this is a registry with data/specimen obtained long ago), a waiver of
consent should be added for IRB review. See <a
href=https://www.slu.edu/Documents/research/IRB/Minors_in_Research.doc target=_blank>SLU
Guidelines for Research Involving Minors for additional detail.
 
     
 2.
If minors are asked to assent and do not wish to participate, will they still be accrued in the study? If
yes, justify.
 
     
 3.
How will the minor's ability to give assent be assessed? (Consider the age and maturity of the minors
as well as their physical or mental condition). If capacity is fluctuating, please explain how capacity
will be assessed throughout the study.
 
  
Note:  For studies that require a discussion about reproductive risks, note that the conversation with the
minor should take place separately from the parents. Also, if a minor will reach adulthood (18 in Missouri)
during the course of the study, they will need to be asked to consent as an adult at that time to continue in
the study.
 
---------------------------------------------------------------------------------------------
* * * HIPAA * * *
15. HIPAA
 
    
 
Studies that access, receive or collect protected health information (PHI) are subject to HIPAA regulations.
PHI is health information with one or more personal identifiers.   For more information visit the  IRB HIPAA
page or refer to the SLU IRB HIPAA Guidance.
 
    1. Will health information be accessed, received or collected?
No health information. HIPAA does not apply.
X
Yes (continue to question 2).
 
    2. Which personal identifiers will be received or collected/recorded?

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
No identifiers.  I certify that no identifiers from the list below will be received or collected and
linked to health information. (Skip remainder of page).
Limited identifiers will be received or collected/recorded (study will likely require a data use
agreement). Select Data Use Agreement- INTERNAL or Data Use Agreement- EXTERNAL as
appropriate, below.
City/State/Zip codes
Person-specific dates (e.g., date of birth, dates of service, admission/discharge dates,
etc.)
Age (if subjects are 90+ years)
X
At least one direct identifier will be received or collected/recorded.
X
Names
Social Security numbers
X
Telephone numbers
Linkable code or any other unique identifying number (note this does not mean the unique
code assigned by the Investigator(s) to code the research data)
All geographic subdivisions smaller than a State, including street address, city, county,
precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip
code, if, according to the current publicly available data from the Bureau of the Census:
(1) The geographic unit formed by combining all zip codes with the same three initial digits
contains more than 20,000 people; and (2) The initial three digits of a zip code for all such
geographic units containing 20,000 or fewer people is changed to 000
X
All elements of dates (except year) for dates directly related to an individual, including
birth date, admission date, discharge date, date of death; and all ages over 89 and all
elements of dates (including year) indicative of such age, except that such ages and
elements may be aggregated into a single category of age 90 or older
Fax numbers
Electronic mail addresses
X
Medical record numbers
Health plan beneficiary numbers
Account numbers
Certificate/license numbers
Vehicle identifiers and serial numbers, including license plate numbers
Device identifiers and serial numbers
Web Universal Resource Locations (URLs)
Internet Protocol (IP) address numbers
Biometric identifiers, including finger and voice prints
Full face photographic images and any comparable images
 
    
  
If you are receiving or collecting/recording health information and at least one personal identifier, please
continue to complete the sections, below.
 
    3. Sources of Protected Health Information:
X
Hospital/medical records for in or out patients
X
Physician/clinic records
X
Laboratory, pathology and/or radiology results

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Biomedical Research
Saint Louis University
Protocol # 28525
Brunworth
Protocol Title:
Randomized trial of Propel stent vs Kenalog-soaked Nasopore after Frontal Drill-out
----------------------------------------------------------------------------------------------------
Biological samples
Interviews or questionnaires/health histories
Mental health records
Data previously collected for research purposes
Billing records
Other
       
     
      
     
Please describe:
 
    4. If data will be shared outside the research team and the study involves PHI indicate how the research
team will share the information.
 
X
Not applicable (continue to question 5).
Only linkable code that can link data to the identity of the subject. A code access agreement or
business associate agreement may be needed when data are shared with other non-SLU
entities. If necessary, the agreement can be added and uploaded in item #5, below.
Limited identifiers: Zip codes, dates of birth, or other dates only. The study qualifies as a Limited
Data Set. A data use agreement may be needed when data are shared with other non-SLU
entities.  If necessary, the agreement can be added and uploaded in item #5, below, using DUA-
external option.
With unlimited identifiers. The consent document and HIPAA Authorization form must describe
how the information will be disclosed.
 
    5. HIPAA Documentation is required for this study.  Use the table below to add HIPAA Documents for
your study.
 
 
HIPAA Documents
HIPAA Documents
Title
Attached Date
HIPAA Authorization
Approved_HIPAA version 2
04/05/2018
Title
Approved_HIPAA version 2
HIPAA Documents
HIPAA Authorization
HIPAA Form
Approved_HIPAA version 2
HIPAA Authorization Template
---------------------------------------------------------------------------------------------