Consumer Evaluation of Intermittent Catheter Product Modifications
Conditions: Urinary Incontinence
Sponsor: Hollister Incorporated

6009-CONT Clinical Protocol 
Consumer Evaluation of 
Intermittent Catheter Product 
Modifications 
  
STUDY SPONSOR 
Hollister Incorporated 
2000 Hollister Drive | Libertyville, IL 60048 | USA 
Company Confidential: No portion of this work may be reproduced in whole or in part without the express written 
permission of Hollister Incorporated. This document contains confidential information for use only by individuals 
participating in the study or evaluation. This document should be maintained in a secure location and should not be 
copied or made available for review by any unauthorized person or firm. Copyright 2020 Hollister Incorporated. 
Caution: Investigational device, limited by Federal (US) law to investigational use. 
 
 
Protocol Release Date: April 13, 2021
NCT04619992

TABLE OF CONTENTS 
1.0 
ABREVIATIONS AND TERMS ................................................................................................................. 4 
2.0 
ETHICS ................................................................................................................................................... 5 
2.1 
IRB Review .................................................................................................................................. 5 
2.2 
Name and Address of IRB............................................................................................................ 5 
2.3 
Adherence to Ethical Principles ................................................................................................... 5 
3.0 
INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE ............................................................ 5 
3.1 
Investigator Responsibilities ....................................................................................................... 5 
3.2 
Sponsor Responsibilities ............................................................................................................. 5 
4.0 
BACKGROUND/RATIONALE .................................................................................................................. 6 
5.0 
STUDY OBJECTIVES ............................................................................................................................... 6 
5.1 
Primary Objective ....................................................................................................................... 6 
5.2 
Secondary Objective ................................................................................................................... 6 
6.0 
STUDY PRODUCTS................................................................................................................................. 6 
6.1 
Investigational Devices ............................................................................................................... 6 
6.2 
Identity of Product, Packaging and Storage, Procedures for Release ........................................... 7 
6.3 
Responsibility for Product Control, Return, and Disposal............................................................. 8 
7.0 
STUDY DESIGN ...................................................................................................................................... 9 
8.0 
STUDY SUBJECTS ................................................................................................................................. 10 
8.1 
Inclusion Criteria for Group 1 .................................................................................................... 10 
8.2 
Inclusion Criteria for Group 2 .................................................................................................... 10 
8.3 
Exclusion Criteria for Group 1 ................................................................................................... 11 
8.4 
Exclusion Criteria for Group 2 ................................................................................................... 11 
8.5 
Subject Treatment and Care ..................................................................................................... 11 
8.6 
Subject Compensation .............................................................................................................. 11 
9.0 
STUDY PROCEDURES .......................................................................................................................... 12 
9.1 
Subject Identification and Recruitment ..................................................................................... 12 
9.2 
Informed Consent ..................................................................................................................... 12 
9.3 
Enrollment................................................................................................................................ 12 
9.4 
Method of Assigning Subjects to Study Groups ......................................................................... 13 
9.5 
Blinding .................................................................................................................................... 13 
9.6 
Prior and Concomitant Therapy ................................................................................................ 13 
9.7 
Study Visits and Evaluation Methods ........................................................................................ 13 
9.8 
Subject Instructions .................................................................................................................. 16 
9.9 
Compliance............................................................................................................................... 16 

9.10 
Subject Withdrawal .................................................................................................................. 16 
10.0 
ADVERSE EVENTS ................................................................................................................................ 17 
10.1 
Handling Adverse Events .......................................................................................................... 17 
10.2 
Reporting Adverse Events ......................................................................................................... 18 
10.3 
Study Stopping Rules ................................................................................................................ 18 
11.0 
DATA MANAGEMENT ......................................................................................................................... 18 
12.0 
STATISTICAL METHODS ...................................................................................................................... 19 
12.1 
Analysis Principles .................................................................................................................... 19 
12.2 
Incomplete Follow-up and Missing Data ................................................................................... 19 
12.3 
Multi-Center and Multiple Comparison/Multiplicity Adjustments ............................................. 19 
12.4 
Sample Size and Power ............................................................................................................. 19 
13.0 
STATISTICAL ANALYSES ...................................................................................................................... 19 
13.1 
Primary and Secondary Objective ............................................................................................. 19 
13.2 
Interim Analyses ....................................................................................................................... 19 
14.0 
STUDY DOCUMENTATION AND RECORD KEEPING .......................................................................... 20 
15.0 
FINAL REPORT ..................................................................................................................................... 20 
16.0 
MONITORING ...................................................................................................................................... 20 
17.0 
AMENDMENT PROCEDURES .............................................................................................................. 20 
18.0 
PROTOCOL ATTACHMENTS ................................................................................................................ 21 
19.0 
REFERENCES ........................................................................................................................................ 22 
20.0 
INVESTIGATOR SIGNATURE ............................................................................................................... 23 
 
 
 
 
 
 

1.0 
 ABREVIATIONS AND TERMS 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
Ch. 
Charriere Size of Catheter (also known as French Size) 
CRF 
Case Report Form 
CRO 
Clinical Research Organization 
GCP 
Good Clinical Practice 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
ePRO 
Electronic Patient Reported Outcomes 
IC 
Intermittent Catheter 
ICH 
International Council for Harmonisation 
ICF 
Informed Consent Form 
IFU 
Instructions For Use 
IRB 
Institutional Review Board 
PHI 
Protected Health Information; any information about health status, provision of health care, 
or payment for health care that can be linked to a specific individual. 
PI 
Principle Investigator 
SAE 
Serious Adverse Event 
Sponsor 
An individual, institution, company, or organization that takes the responsibility to initiate, 
and manage a clinical trial. For the purposes of this study, the Sponsor is Hollister 
Incorporated. 
Study Product 
The product being evaluated in the clinical study. For the purposes of this protocol, the Study 
Product is a 
 single-use hydrophilic intermittent catheter 
 
  
Sub-I 
Sub Investigator 
TMF 
Trial Master File 
UAE 
Unexpected Adverse Event 
USA 
United States of America 
 
 
 
 

2.0 
 ETHICS 
2.1 IRB Review 
This non-significant risk clinical study, including the Informed Consent, will be reviewed by an Institutional 
Review Board (IRB) in accordance with Title 21 of the Code of Federal Regulations (CFR), Parts 50 and 56. 
Approval by the Board will be obtained prior to the initiation of the study. 
 
This study is considered of minimal risk in that the anticipated risks of harm are no greater, considering 
probability and magnitude, than those ordinarily encountered in the daily routine of the subjects.  This 
definition is consistent with 21CFR §§ 56.102(i). 
2.2 Name and Address of IRB 
The study and any amendments will be reviewed by the following IRB: 
BRANY IRB (Formerly Asentral IRB) 
Biomedical Research Alliance of New York LLC 
1981 Marcus Avenue, Suite 210 
Lake Success, NY 11042 
 
The IRB above meets the FDA’s definition of an Independent Ethics Committee as defined in 21 CFR 
812.3(t). Records to support the above statement can be found in the sponsor’s Trial Master File (TMF). If 
additional, or local, IRB approval is required per individual site requirements, records will be stored in the 
sponsor’s TMF.  
2.3 Adherence to Ethical Principles 
The study will be conducted in accordance with the ethical principles that have their origins in the 
Declaration of Helsinki. 
3.0 
 INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE 
Hollister Incorporated is the Sponsor and financer of this clinical study.  The Principal Investigator (PI), Sub-
Investigator(s) (Sub-I), and study administrative team (data manager, statistician, etc.) are employees of the 
Sponsor. Hollister Incorporated is the acting clinical site for this at-home panel study.  
3.1 Investigator Responsibilities 
It is the responsibility of the PI and Sub-I to follow applicable Good Clinical Practice (GCP) guidelines and 
regulations including: complying with the protocol procedures, overseeing enrollment of appropriate 
subjects, addressing subjects’ questions or concerns, evaluating and reporting Adverse Events (AE), 
ensuring Informed Consent is properly obtained, and retaining all study related documents for 
 
 (or according to local authorities guidelines on record retention) once the study is officially 
closed. 
3.2 Sponsor Responsibilities 
It is the responsibility of the sponsor, Hollister Incorporated, to oversee the overall conduct of the clinical 
study and verify study procedures are adhered to by the Investigator(s). The Sponsor will also maintain 
accurate product accountability and maintain shipping records for study product. Hollister Incorporated 

may transfer any or all trial-related duties and functions to a CRO or vendor, but the ultimate responsibility 
for the quality and integrity of the study data resides with the sponsor, per ICH Good Clinical Practice 
5.2.1. 
4.0 
 BACKGROUND/RATIONALE 
Hollister Incorporated has developed 
 hydrophilic 
 technology 
 
 
 Prior to launching 
 
 technology, Hollister plans to collect feedback from end users 
 
 
 
5.0 
STUDY OBJECTIVES 
5.1 Primary Objective 
The primary objective of this study is to assess 
 hydrophilic 
 technology used on the study 
product. Assessment data will be collected to determine whether end users find the 
 hydrophilic 
 technology to be 
 acceptable 
 
 
 Product safety will also be monitored 
through daily questionnaires intended to track adverse events.  
5.2 Secondary Objective 
The secondary objective is to generate evidence to support commercial 
 objectives 
 
. 
6.0 
 STUDY PRODUCTS 
6.1 Investigational Devices 
The study product 
 is a straight, hydrophilic, 
Intermittent Catheter 
 The original product, 
, is 
marketed by Hollister Incorporated 
. The hydrophilic 
 
product has been modified 
. 
Additionally the catheter 
 have design enhancements that the 
study participants may not have seen prior. 
 
 
 The study product is packaged as a box of thirty (30), 
individually wrapped, 
 single-use, hydrophilic intermittent catheters. 

 
The study product shall be used with end users who currently use a 
 IC product or have sampled a 
 IC according to protocol procedures, self-catheterize a minimum of 
, and are 
familiar with how to properly use an IC per the Instructions For Use (IFU).  This study is considered of 
minimal risk in that the anticipated risks of harm are no greater, considering probability and magnitude, 
than those ordinarily encountered in the daily routine of the subjects.  This definition is consistent with 
21CFR §§ 56.102(i). 
 
The study product to be used in this study is 
.  Class II devices are those 
for which general controls alone are insufficient to assure safety and effectiveness, and additional existing 
methods are available to provide such assurances. Therefore, Class II devices are also subject to special 
controls in addition to the general controls of Class I devices. Special controls may include special labeling 
requirements, mandatory performance standards, and post market surveillance.  Devices in Class II are 
held to a higher level of assurance than Class I devices to insure that they will perform as indicated and 
will not cause injury or harm to patient or user. 
6.2 Identity of Product, Packaging and Storage, Procedures for Release 
The study product 
 will be manufactured and released according to the Sponsor’s 
Authorization for Release of Clinical Product 
 
 
 
 The study product 
shall be manufactured and supplied under Clinical Manufacture Protocol 
.  
 
The study product will be labeled 
 prior to study initiation using the following labels: 
 
 
 
 
 
 

 
 
6.3 Responsibility for Product Control, Return, and Disposal 
Before dispensing product 
 to subjects, the following steps must be taken 
 
 
A. Potential subject completes their ‘Informed Consent Form’ (ICF) and ‘Authorization for Release of 
Information’ form 
 
 
 
B. If potential subject is found to be eligible for the study via the eligibility screener, Research Staff 
will make attempts to verify the potential subject 
 

D. Following completion of steps 
, product can be shipped (dispensed) to the subject.  
 
Anytime study product is dispensed to a subject, research staff will document it in the Electronic Data 
Capture (EDC) System on 
.  Product shipment 
documentation including shipment tracking numbers will also be retained by the sponsor.  
 
Used study catheters will be discarded by subjects after each use, according to their normal practice and 
as stated in the product IFU. Any unused study catheters will be returned to the Sponsor at the end of the 
subjects’ participation in the study using the 
 provided to them. Sponsor 
will document the date and number of returned IC in the EDC System on 
 
 
7.0 
STUDY DESIGN 
The study will be executed at a 
, and 
will not require 
 
 Subjects will be assigned to one of two possible study Groups. Group 1 will include subjects who 
currently use 
 IC products. Group 2 will include subjects who currently do not use 
 IC products 
but do use 
. Subjects will be assigned either to Group 1 or 
Group 2 depending on their current hydrophilic IC product usage at time of completing the eligibility 
screener.  
 
Subjects in Group 1 will be shipped 
 to use over a consecutive 
. Subjects will be instructed to use Study Catheter  according to their usual care practices. 
After each day, subjects will complete a daily check-in to confirm the number of ICs they have remaining 
and if there have been changes in their overall health. Once the subject uses all of 30 study catheter  or 
 have elapsed, whichever occurs first, the subject will complete an end-of-study questionnaire 
about their overall experience. 

 
Subjects in Group 2 will be shipped 
 IC  
 
 Subjects will first sample 
the currently marketed product for a 
, or until they use a maximum of 60 Study Catheter 
 
whichever occurs first (“sampling period”). After the sampling period, subjects will switch to using Study 
Catheter  Subjects will use the study Catheter  for a consecutive 
, or until they have used 
all 30 Study Catheter 
 whichever occurs first.  Subjects will be instructed to use both study catheters 
according to their usual care practices. After each day, subjects will complete a daily check-in to confirm 
the number of ICs they have remaining and if there have been changes in their overall health. After using 
both study catheters, the subjects in Group 2 will complete an end-of-study questionnaire about their 
overall experience. 
8.0 
STUDY SUBJECTS 
In order to be eligible for participation in this study, each study participant must meet the following inclusion and 
exclusion criteria.
 
 
8.1 Inclusion Criteria for Group 1 
Subject who: 
1. is male and at least 18 years of age  
2. can speak, read, and write in English 
3. has been performing unassisted, self-catheterizations, with a Hydrophilic IC, for at least 1 month 
4. is self-catheterizing 
 
5. currently uses a 
 IC and has been for at least 2 weeks 
6. is willing to provide permission and the means for study staff to contact 
 
 
7. is willing and able to follow the study protocol procedures including completing 
 
questionnaires as demonstrated by signing the Informed Consent 
 
8.2 Inclusion Criteria for Group 2 
Subject who: 
1. is male and at least 18 years of age  
2. can speak, read, and write in English 
3. has been performing unassisted, self-catheterizations, for at least 1 month 
4. is self-catheterizing 
 
5. currently uses a  Hydrophilic IC in 
. Examples of other 
hydrophilic IC include but are not limited to: 

6. is willing to provide permission and the means for study staff to contact 
 
 
7. is willing and able to follow the study protocol procedures including completing online 
questionnaires as demonstrated by signing the Informed Consent 
8.3 Exclusion Criteria for Group 1  
Subject who: 
1. is currently undergoing chemotherapy, radiation or steroid therapy 
2. has a symptomatic urinary tract infection (UTI) 
 
 
5. is currently using a 
 product to perform catheterization 
6. Performs 
 catheterization 
 
 
8.4 Exclusion Criteria for Group 2 
Subject who: 
1. is currently undergoing chemotherapy, radiation or steroid therapy 
2. has a symptomatic urinary tract infection (UTI) 
 
 
 
6. is currently using a 
 product to perform catheterization 
7. Performs 
 catheterization 
 
 
 
8.5 Subject Treatment and Care 
All subject care will be consistent with standard health care practices. Subjects will report any changes in 
their health status during the course of the study 
. Subjects 
who report health problems may be directed by the PI or designee to seek care from their 
 
  The PI or designee will follow up 
 
 with subjects about any 
 that occur until it has resolved for up to 
 after 
study completion. 
8.6 Subject Compensation 
Subjects
 will be offered
 for their participation 
in the study. Compensation will be paid out by the Sponsor 
 
 subject completing the study procedures. 

9.0 
STUDY PROCEDURES 
9.1 Subject Identification and Recruitment 
Subjects will be recruited from 
. Possible methods to identify and recruit end users may 
include but are not limited to: 
 
Once identified as a possible subject, subject will be assigned a 
 Study ID 
 by 
the Sponsor. 
 
 
 
 
 
 
 
 
 
 
9.2 Informed Consent 
Potential subjects will receive 
 a link to the IRB-Approved, 
electronic ICF. The ICF will further explain the nature and purpose of this study to the subjects. Each 
subject will have the opportunity to ask questions before deciding whether to participate, and will be 
informed they may end their participation at any time. If the subject decides to participate, they will 
electronically sign and date the ICF.  If the subject is ultimately eligible for the study, the Sponsor will 
include a paper copy of the executed ICF with the study product that is mailed to them.  
 
 
 
 
9.3 Enrollment 
Once informed consent is verified, the potential subject will be 
 
 screen for inclusion/exclusion eligibility criteria. If a subject meets 
screening criteria, 
 
 the subject will be formally 
enrolled into the study.  If the subject does not meet the screening criteria, the reason for screen-fail will 
be documented within the EDC and the subject will not be enrolled into the study. 
 
  

9.4 Method of Assigning Subjects to Study Groups 
All subjects will be assigned to one of two possible study Groups.  Group 1 will include subjects who 
currently use 
 IC products. Group 2 will include subjects who currently do not use 
 IC products 
but do use a different type of 
 IC on the market, as defined in the eligibility criteria in Sections 
8.1 and 8.2. Subjects will be assigned either to Group 1 or Group 2 depending on their current IC product 
reported at time of completing the eligibility screener.  
9.5 Blinding 
There is no blinding in this study.  All study product is open label. 
9.6 Prior and Concomitant Therapy 
See Sections 8.1 – 8.2 Inclusion Criteria and Sections 8.3 – 8.4 Exclusion Criteria  for pertinent prior and 
concomitant therapy requirements. 
9.7 Study Visits and Evaluation Methods 
Subjects in Group 1 are enrolled into the study for up to 
. The 
 begins the day 
they use their first study product. Subjects are expected to use 
 ICs 
, according to 
their typical routine
 Study events include completion of electronic ICF, 
eligibility screening form, baseline form, daily questionnaires, and one end-of-study questionnaire.  There 
are no in-person study visits during this study. Subjects will use and evaluate the study product at their 
respective homes. Study events for the subjects in Group 1 are summarized below: 
 
 

Subjects in Group 2 are enrolled into the study for 
 a 
 period 
followed by a 
 evaluation. 
 The 
 begins the day they use their first Study Catheter 
 Subjects will use Study Catheter  
until the 
 period ends, or they use all 
 Catheter  provided, whichever occurs first. 
Subjects will then switch to using Study Catheter  immediately without interruption. The 
 begins the day they use their first study Catheter  Subjects are expected to use 
 
 ICs 
 according to their typical routine
. Study events include 
completion of electronic ICF, eligibility screening form, baseline form, daily questionnaires, and one end-
of-study questionnaire.  There are no in-person study visits during this study. Subjects will use and 
evaluate the study product at their respective homes. Study events for the subjects in Group 2 are 
summarized below: 
 

 
9.8 Subject Instructions 
Subjects will be provided 
 Instructions for Use 
 
 depending on which 
Group they have been assigned to. The IFU provided to the subject are based on the currently approved 
IFU for the currently marketed 
 product. The steps to use Study Catheter 
 remain the 
same as the currently marketed product. The participant study instructions include steps for completing 
the study procedures/questionnaires and contact information for research staff if they experience any 
issues while participating in the study.  
9.9 Compliance 
Subjects are expected to fully comply with the protocol procedures and study instructions.  If a subject 
deviates from the protocol at any point, study staff will use 
 to document 
the event in the EDC system.   
 
The site will be monitored for compliance. If site is found to have multiple deviations, corrective action or 
re-training may be necessary. 
9.10 Subject Withdrawal 
Subjects may elect to withdraw from the study at any time for any reason. Data collected up to the point 
of withdrawal will be eligible for analysis, unless the subject documents in writing to the PI that they refuse 
use of any and all of their data for analysis. Any new information gained during the study that might affect 
the subject’s desire to continue participation will be conveyed to them in a timely manner. These 

procedures are expressed in the ICF that the subject signs. Subjects electing to withdraw from the study 
are required to return all unused study product. 
 
The Investigator may discontinue a subject from the study at any time without prejudice.  
Discontinuations are documented on 
 in the EDC system. 
Furthermore, the Sponsor may end the study at any time.   
10.0 ADVERSE EVENTS 
An Adverse Event (AE) is any untoward medical occurrence experienced by a subject, which does not necessarily 
have to be related to the device under investigation.  An AE can therefore be any unfavorable and unintended 
sign, symptom, or disease experienced while also using the device, whether or not considered related to the 
device.   
• 
Based on literature evaluation, expected adverse events that could occur in subjects recruited for this 
study include: 
 
 
 These are possible risks with any 
intermittent catheter usage on the market and are not unique for the study product. 
 
A Serious Adverse Event (SAE) is one that results in death, results in life-threatening illness or injury, requires in-
patient hospitalization or prolongation of hospitalization, results in medical intervention to prevent permanent 
impairment, or results in permanent impairment of body structure or function, or that result in injury or death to 
a fetus.    
• 
There are no SAE related to the study product anticipated in this study.  
 
An Unanticipated Adverse Event (UAE) occurs when the nature, severity, or frequency of the event is not 
consistent with the known or foreseeable risk of the anticipated adverse events associated with the study product 
or procedures involved with this research. 
10.1 Handling Adverse Events 
Upon study enrollment, all subjects are informed to notify the Investigator immediately if they experience 
any health or study-related problems. Subjects will be asked daily to report any change in their health 
status during the course of the study on the Daily Questionnaires 
. The 
PI or designee will contact the subject if clarification of the information reported on the daily form is 
needed. The PI will determine if an AE has occurred, the severity of the AE, and if it was related to the 
study product.  AEs will be documented on 
 in the EDC system.  
Subjects who report AEs may be directed to seek care from their healthcare provider or emergency room, 
as appropriate.   
 
All AEs are followed to determine resolution for up to 
 by the Investigator and the Adverse Event 
Form is updated to indicate date of resolution.  If at any point, the Investigator determines the subject 
should no longer remain on the study product, the subject should be discontinued from the study. 

10.2 Reporting Adverse Events 
Unanticipated Adverse Events (UAE) and Serious Adverse Events (SAE) related to the study product must 
be reported by the Investigator or Sub-Investigator through the EDC system within 
 by 
documenting on 
. 
 
Investigators are also required to submit a report of SAE to IRB as soon as possible, but in no event later 
than 
 after the investigator first learns of the event (Guidance for Clinical Practice Adverse 
Event Reporting to IRBs Improving Human Subject Protection , 2009). 
10.3 Study Stopping Rules 
All adverse events will be evaluated and handled according to procedures in Section 11.1. 
 
 
11.0 DATA MANAGEMENT 
It is the responsibility of the Investigator to ensure the completeness and accuracy of all study data collected in 
the EDC system. Subject name and contact information will be treated as Protected Health Information and not 
included in any dataset for analysis.  All datasets for study analysis will include only de-identified data. 
 
The electronic ICF and electronic case report forms (eCRFS) will be collected directly from research subjects using 
a secure, cloud-based EDC and electronic patient reported outcomes (ePRO) system 
.  
 will 
be configured by the Sponsor Data Manager for study-specific data capture.  Study forms such as the Adverse 
Event Form, Protocol Deviation Form, and Contact Log will be entered by the study personnel at the site.  
 
Subjects will be provided with a link to the EDC/ePRO system via an email, as each study form is made available 
to them to complete.  Subjects will set up their own, secure password to the system and that password remains 
unknown to the Sponsor. The 
 EDC will provide an audit log that verifies that all ePRO data were entered 
by the subjects themselves. The audit log will also document when and by whom any modifications were made to 
the data after initial entry. 
 
To the best of the Sponsor’s ability, data logic and validation checks will be configured in the ePRO system so that 
subjects will receive warning messages at time of entry regarding inconsistent or invalid entries, in order to assure 
quality and completeness of data. Because the study collects self-report data directly from the study participants, 
there will be minimal corrections or modifications by the Sponsor to ePRO data. Any modification of any ePRO 
data will only be done following direct contact and clarification from the research subject. There will be no 
modification to any data capturing subject opinion or assessment of study product.  The Sponsor may contact the 
subject to clarify factual data, such as date of first study product use, or any unclear responses on  the ICF and the 
Eligibility Screener, to assure proper and full consent of subjects, as well as confirmation of eligibility before study 

enrollment.  The Sponsor will contact any subject who directly reports or implies a change in their health status, 
in order to assure subject safety while using the study product.  
 
Access and permissions to the EDC system for data entry, approval signatures, and/or data export are controlled 
by user identification and password, which are provisioned by the Sponsor. Investigators and other study 
personnel are trained by the Sponsor in the use of the EDC and application of electronic signatures before the 
start of the study. The Study Investigator will electronically sign all study data captured in the EDC, 
 prior to data export and analysis. 
12.0 STATISTICAL METHODS 
12.1 Analysis Principles 
Enrolled subjects who provide product assessment data will be eligible for analysis; subjects who screen 
fail or did not provide any study product assessment data will be excluded from analysis. 
12.2 Incomplete Follow-up and Missing Data 
In the event that a subject does not complete the full study period, the complete set of data available for 
that subject prior to loss-to-follow-up will be used for analysis. No imputation of missing data will be 
performed.  
12.3 Multi-Center and Multiple Comparison/Multiplicity Adjustments 
Data collected from all study sites will be combined and analyzed as a whole. No multi-center adjustments 
will be made.  
12.4 Sample Size and Power 
A sample size of 
 end-users was chosen to attain a margin of error of approximately 
. Assuming a 
 dropout rate, up to 
 end users will be enrolled to reach a target final sample size of up to 
 
13.0 STATISTICAL ANALYSES 
13.1 Primary and Secondary Objective 
Study data collected will be analyzed using appropriate statistical methods as defined by the variable’s 
data level (i.e. continuous, ordinal, categorical, etc.). This includes but is not limited to frequency and 
percentages for categorical measures and mean [standard deviations] for continuous measures. 
 
13.2 Interim Analyses 
An interim analysis is planned for when one of the following milestones occur, whichever occurs first: 1) 
 subjects have provided product assessment data via the end of study questionnaire or 2) the study 
reaches 
.  All subject data that has been gathered and released 
 on or prior 
to this milestone will be included in the interim analysis. 
 
 Any amendments will be documented per Section 
17.0. 

14.0 STUDY DOCUMENTATION AND RECORD KEEPING 
The Sponsor and clinical site are required to retain essential study documents within a study TMF. The Sponsor is 
responsible to retain study documentation per the retention schedule set forth in 
 Clinical 
sites other than Hollister Incorporated are required to retain study documentation for 
 
following Sponsor notification of study closure.  
15.0 FINAL REPORT 
The Sponsor will write and issue an interim report per the schedule provided in Section 13.2 and a final report at 
study completion. It is the responsibility of the Investigator to provide the interim and final reports to the IRB, as 
required. In the event that the target sample size is enrolled and available for analysis by the time of the planned 
interim analysis, a final report will be issued in lieu of an interim report and a note to file will be created to 
document this event. 
16.0 MONITORING 
A qualified Hollister Incorporated monitor or designee will monitor the study data to verify that forms are 
completed, and that the conduct of the trial is in compliance with the currently approved protocol/ amendment(s) 
procedures, GCP, and any applicable regulatory requirements. 
 
All data collected for this study is subject self-report data via ePRO questionnaire, and therefore there will be no 
source documents for monitoring.  To the best of the Sponsor’s ability, data logic and validation checks will be 
configured in the EDC ePRO module so that subjects will receive warning messages at time of entry about 
inconsistent or invalid entries, in order to assure quality and completeness of data. Since the study collects 
 there will be minimal corrections or modifications by the Sponsor to ePRO 
data. Any modification of ePRO data will only be done following direct contact and clarification from the subject. 
There will be no modification to any data capturing subject opinion or assessment of study product.  The Sponsor 
may contact subjects to clarify factual data, such as date of first study product application, or any unclear 
responses on the ICF and the Eligibility Screener, to assure proper and full consent of subjects, as well as 
confirmation of eligibility before study enrollment.  The Sponsor will contact any subject who directly reports or 
implies a change in their health status, in order to assure subject safety while using the study product. 
17.0 AMENDMENT PROCEDURES 
The Sponsor is responsible for initiating any protocol amendments. The amendments will be reviewed by the PI 
and approved by the IRB before they are implemented. Investigator(s) are notified of changes, and a copy of the 
amendment is kept in the TMF.  
 
 

18.0 PROTOCOL ATTACHMENTS 
 
 

19.0 REFERENCES 
 
1. FDA. Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors Significant Risk 
and Nonsignificant Risk Medical Device Studies https://www.fda.gov/media/75459/download 
 
2. FDA. Guidance for Clinical Practice Adverse Event Reporting to IRBs Improving Human Subject 
Protection . (2009, January). Retrieved from 
https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm126572.pdf 
 
 
6. ICH Harmonised Guideline for Good Clinical Practice Section 5.2.1. (2015, June 11). Retrieved 
from 
https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2_
_Addendum_Step2.pdf 
 
7. Title 21 of the Code of Federal Regulations Parts 11, 50 54, 56, 812 
 
8. World Medical Association. (2018). Declaration of Helsinki – Ethical Principles for Medical 
Research Involving Human Subjects. 
 
 
 
 
 
 
 
 
 
 
 

20.0 INVESTIGATOR SIGNATURE 
I have read the foregoing protocol and agree to conduct the study as outlined herein. Electronic 
signatures may be used (where possible) in lieu of traditional signatures.