Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma
Phase: NA
Conditions: Ileostomy - Stoma, Colostomy Stoma
Sponsor: Coloplast A/S

 
 
Page 1 of 67 
 
CONFIDENTIAL 
 
 
Clinical Investigation Plan 
 
CP300 
Assessment of new enhanced ostomy device in real-life settings 
in subjects having a stoma 
November 2018 – March 2019 
Master 
This confidential document is the property of Coloplast A/S. 
No unpublished information contained herein may be 
disclosed without written approval of Coloplast A/S. 

 
 
Page 3 of 67 
 
CONFIDENTIAL 
 
 
VERSION 
NUMBER 
ISSUED BY 
(INITIALS) 
COMMENTS (MAJOR CHANGES SINCE LAST REVISION) 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
  
 
    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
Page 4 of 67 
 
CONFIDENTIAL 
 
 
> 
TABLE OF CONTENTS 
1. 
List of personnel involved in the Investigation ...................................................... 9 
1.1. Sponsor representatives ................................................................................................. 9 
1.2. Investigators ..................................................................................................................... 9 
1.3. Other ............................................................................................................................... 10 
2. 
Identification and description of the investigational device ............................... 11 
2.1. Manufacture .................................................................................................................... 11 
2.2. Description of investigational device ........................................................................... 11 
2.3. Identification, traceability and labelling of device ....................................................... 11 
2.4. Clinical investigation intended use of device .............................................................. 12 
2.5. Intended population for the device ............................................................................... 12 
2.6. Handling and training .................................................................................................... 12 
2.7. Comparator product(s) .................................................................................................. 13 
3. 
Justification for the conduct of the clinical investigation ................................... 14 
4. 
Investigational device and clinical investigation risks and benefits .................. 15 
4.1. Anticipated clinical benefits .......................................................................................... 15 
4.2. Anticipated risks and disadvantages ........................................................................... 15 
4.3. Benefits versus risks ..................................................................................................... 16 
5. 
Aim, objectives and hypotheses of the clinical investigation............................. 17 
5.1. Aim .................................................................................................................................. 17 
5.2. Objective ......................................................................................................................... 17 
5.3. Hypotheses ..................................................................................................................... 17 
6. 
Design of the clinical investigation ....................................................................... 18 
6.1. General ........................................................................................................................... 18 
6.2. Investigational device and comparator(s) .................................................................... 27 
6.3. Subjects .......................................................................................................................... 27 
6.4. Procedures ..................................................................................................................... 31 
6.5. Supplementary material and equipment....................................................................... 40 
6.6. Monitoring Plan .............................................................................................................. 40 
7. 
Statistical considerations ...................................................................................... 43 
7.1. Statistical design, method and analytical procedures ................................................ 43 
7.2. Sample size .................................................................................................................... 44 
7.3. Level of significance and power ................................................................................... 45 
7.4. Drop-out .......................................................................................................................... 45 
7.5. Pass/fail criteria.............................................................................................................. 45 

 
 
 
Page 5 of 67 
 
CONFIDENTIAL 
 
 
7.6. Interim analysis .............................................................................................................. 45 
7.7. Statistical reason for termination of investigation ...................................................... 45 
7.8. Deviation(s) from statistical plan .................................................................................. 46 
8. 
Data management ................................................................................................... 46 
8.1. Data review, database cleaning, and issuing and resolving data queries ................. 46 
8.2. Verification, validation and securing of electronic clinical data systems .................. 46 
8.3. Data retention ................................................................................................................. 46 
9. 
Amendments to the CIP ......................................................................................... 47 
10. 
Clinical Investigation Plan deviations ................................................................... 48 
10.1. 
Deviations ................................................................................................................... 48 
10.2. 
Violations .................................................................................................................... 48 
11. 
Device Accountability ............................................................................................. 49 
12. 
Statement of compliance ....................................................................................... 50 
12.1. 
Ethics committee and regulatory authorities ............................................................ 50 
12.2. 
Data protection ........................................................................................................... 50 
12.3. 
Indemnity ..................................................................................................................... 51 
12.4. 
Financial conditions ................................................................................................... 51 
13. 
Informed consent process ..................................................................................... 51 
14. 
Adverse events, serious adverse events and device deficiencies ..................... 53 
14.1. 
Adverse events ........................................................................................................... 53 
14.2. 
Device deficiency ........................................................................................................ 54 
14.3. 
Serious adverse events .............................................................................................. 54 
14.4. 
Medical care of subjects ............................................................................................. 55 
14.5. 
Reporting and timelines ............................................................................................. 55 
15. 
Suspension or premature termination of the clinical investigation ................... 57 
16. 
Clinical investigation report ................................................................................... 58 
17. 
Publication policy ................................................................................................... 59 
17.1. 
General ........................................................................................................................ 59 
18. 
Bibliography ............................................................................................................ 60 
20. 
Appendix ................................................................................................................. 61 
20.1. 
Appendix 1: LOCAL CHANGE LOG ........................................................................... 61 
20.2. 
Appendix 2: Leakage scale questionnaire ................................................................ 62 
20.3. 
Appendix 3: Quality of life questionnaire .................................................................. 64 
20.4. 
Appendix 4: Safety Interview guide ........................................................................... 66 
20.5. 
Appendix 5: Interview guide (V6) and Follow-up ...................................................... 67 
 

 
 
 
Page 8 of 67 
 
CONFIDENTIAL 
 
 
> 
SIGNATURE PAGE  
All parties declare by their signature on the electronic or the separate signature page to follow the Clinical 
Investigation Plan CP300 in accordance with the Declaration of Helsinki, ISO 14155 and the Medical Device 
Directive/Medical Device Regulation.  
 
 

 
 
 
Page 9 of 67 
 
CONFIDENTIAL 
 
 
1. List of personnel involved in the Investigation 
1.1. Sponsor representatives 
In case of emergency, please contact the Coordinating Clinical Manager from the above list of sponsor repre-
sentatives. 
 
 
1.2. Investigators 
The Coordinating Clinical Manager is responsible for maintaining an updated Site Personnel Contact Details 
list of all Principal Investigators, investigation sites and institutions. Details of all Principal Investigators, inves-
tigators, including a CV, are maintained in the Sponsor File. 
 

 
 
 
Page 10 of 67 
 
CONFIDENTIAL 
 
 
Qualified site personnel can perform investigation related tasks as investigator representatives. This delega-
tion will be documented in the “Site Personal Signature and Delegation List” for each site. All investigators and 
investigator representatives will receive oral and written training in all investigation related tasks before they 
can begin any investigation related tasks. The training will be documented in the Clinical Investigation Training 
Log at each site. 
 
1.3. Other  
CROs may be used to help conduct the investigation as Sponsor representatives in one or more countries. 
The CROs, their role and responsibilities will be listed in the Site Personnel Contact Details list.  
 
 

 
 
 
Page 13 of 67 
 
CONFIDENTIAL 
 
 
All Investigators / investigator representatives will receive training by sponsor / investigator in the handling and 
correct use of the test products. The Investigator/investigator representative will train the subjects in the correct 
use of the test products.  
2.7. Comparator product(s) 
As the comparator product is already on the market and will be used within the intended use in this clinical 
investigation, it is not considered an investigational device according to ISO 14155:2011 and is thus not de-
scribed here. Please refer to the ISO 14155:2011 for details. 
 

 
 
 
Page 14 of 67 
 
CONFIDENTIAL 
 
 
3. Justification for the conduct of the clinical investigation 
People with abdominal stomas (especially ileostomists) have, despite development of better stoma products, 
problems with leakage 
influence quality of life negatively [2]. To overcome this, 
Coloplast A/S has developed a new stoma product with a baseplate 
 The aim is to seek knowledge of whether the new baseplate can protect the skin 
 
  
 
 

 
 
 
Page 15 of 67 
 
CONFIDENTIAL 
 
 
4. Investigational device and clinical investigation risks and benefits 
The clinical investigation is conducted in accordance with current law and applicable standards (see section 
12). The rights, safety and well-being of the subjects shall prevail over science and society. All investigators 
and investigator representatives will be instructed in performing their job with conscientiousness and care.  
4.1. Anticipated clinical benefits 
The test products contain a 
 
 The outcome of this investigation will contribute with important information 
for development of products for subjects with a stoma, regarding
 
 
4.2.  Anticipated risks and disadvantages 
Anticipated risks 
A number of risks connected to use of the test product have been identified in the Product Risk Assessment. 
All risks will be mitigated before release of products for the clinical investigation. The risk management process 
has been performed in accordance with the requirements stated in ISO 14971:2012 and in accordance with 
internal Coloplast procedures, including design verification, validated test methods, risk analysis and comple-
tion of a biological report for the test product.  
The following risks will also be mitigated by actions during the clinical investigation, specified in this Clinical 
Investigation Plan: 
- 
Irritated skin (intact or non-intact): Use of the product can lead to intact or non-intact irritated skin. 
To mitigate and reduce the risk, the users will be trained, according to the IFU, in preparation of the 
product (e.g. hole size), preparation of skin before application (e.g. cleaning and wiping), application 
of product (e.g. correct position and applying pressure to the baseplate), removal of product and stor-
age of the product.    
 
- 
Strangulation of a stoma, 
 was stated as the 
root cause to a Serious Adverse Event in a previous clinical investigation (CP2643). Therefore,  
 
 
 
 
 
Residual risks 
Residual risks will be assessed after mitigation of the risks.  
 
Disadvantages 
Disadvantages during the investigation could be the extra workload related to completion of questionnaires, 
visits at site and using the clinical app at each change of product.  
 
 
3 Danish Ethical Committee registration number: H-17031767 
  Danish Competent Authorities registration number: 2017102759 and CIV-ID: CIV-17-10-02-021866 

 
 
 
Page 16 of 67 
 
CONFIDENTIAL 
 
 
Interactions with concomitant medication 
There is no known interaction between the use of the stoma products used in the clinical investigation and 
concomitant medication.   
 
4.3. Benefits versus risks 
The participating subjects will contribute with important information for development of new stoma products, 
that may have less negative impact om the peristomal skin. Due to the actions taken to mitigate the above-
mentioned risks, the risks and disadvantages when participating in this clinical investigation are estimated as 
low. The subject’s heath will not benefit directly from this investigation but they may benefit from the use of the 
new stoma product through less irritated peristomal skin and improved quality of life and in the future.  
 
 
 

 
 
 
Page 18 of 67 
 
CONFIDENTIAL 
 
 
6. Design of the clinical investigation 
6.1. General 
This investigation is a controlled, comparative, multicentre investigation, that consist of two test periods. During 
Test Period 1 the subjects will be asked to use SenSura® Mio (Comparator) for baseline data for 14 (-2/+15) 
days. Hereafter the subjects will be asked to use the test product for 28 (-4/+12) days during Test Period 2. 
During the test periods the subjects can change their product as often as needed, but at least every third day.   
Before the test periods the subjects are invited for an inclusion visit (V0). Subjects sign all consent forms at 
this visit before continuing the investigation. Hereafter, the subjects will complete five test visits (V1, V2, V4, 
V5 and V6) and one safety visit at site (V3). After termination, a follow-up visit may be conducted at the sub-
ject’s home. 
Biological materials (faeces) will be collected during the investigation for analysis only related to this investi-
gation. Therefore, an Investigational BioBank will be created for this purpose. The samples of biological mate-
rials will be stored in a separately CP300 allocated freezer at site, and send on an ongoing basis to Coloplast 
A/S, Humlebæk, Denmark. The samples of biological materials will not be stored longer than it takes to collect 
and analyse the samples. The sample will be destroyed directly after analysis. The Biobank will be closed 
when all output samples have been analysed and destroyed, or at three months after last patient out. 
Please see section 6.4.1 Clinical Investigation-related Procedure for more information about procedures during 
the investigation. 
 
 
 

 
 
 
Page 25 of 67 
 
CONFIDENTIAL 
 
 
6.1.3. Baseline data 
Registered at the inclusion visit (V0) by Investigator or a delegate hereof 
- 
Date of informed consent (date) 
- 
Date of visit (date) 
- 
Check of inclusion criteria 
- 
Check of exclusion criteria 
- 
Subject number (number) 
 
Demographic 
- 
Date of birth (date) 
- 
Gender (male/female) 
- 
Height (number - cm) 
- 
Weight (number – kg) 
 
Stoma 
- 
Age of stoma (year when created) 
- 
Type of stoma (ileostomy/colostomy) 
- 
Cause of the stoma (Crohn's disease/Colitis ulcerosa/ Cancer/ Other) 
- 
Size of the stoma (diameter on widest place and height) 
- 
Shape of the stoma (round/oval/irregular) 
- 
Does your stoma change colour? (Yes/No) 
• If yes, please describe 
 
- 
Does your stoma sometimes secrete excessively (weeping stoma)? (Yes/No) 
• If yes, please describe? 
 
- 
Does your stoma change shape (change in diameter, change in length)? (Yes/No) 
• If yes, please describe? 
 
- 
Does your stoma bleed regularly? (Yes/No) 
• If yes, please describe? 
 
- 
Does your stoma change behaviour due to?  
• exercise? (Yes/No) 
• if yes, please describe 
• specific foods? (Yes/No) 
• if yes, please describe 
• hydration level? (Yes/No) 
• if yes, please describe 
• Other? (Yes/No) 
• If yes, please describe 
Current product 
- 
What is your Current product (brand, product name, item number, size, product type (1-piece) 
- 
Are you used to cut the baseplate? (Yes/No)  
• 
If yes, how much is cut off from the baseplate (template of the baseplate where the cut is drawn upon, 
max cut in mm)? 
 
Peristomal skin area 

 
 
 
Page 30 of 67 
 
CONFIDENTIAL 
 
 
• Be at least 18 years of 
age 
First contact 
The identified potential sub-
jects will as first contact be 
sent an Invitation and Reply 
Letter by mail or email.  
Interested subject contact 
the investigator. 
The identified potential sub-
jects will be contacted and in-
formed about the investigation 
by the investigator (via tele-
phone, letter or e-mail). 
 
If a potential subject does 
not return the reply letter or 
answer the email, they may 
be contacted by phone, mail 
or email to make sure that 
they have received the ap-
proach.   
Second contact 
If potential subjects return the Reply Letter/reply to the email, or have called the investigator as 
first contact and are interested, the Investigator or delegated site personnel will contact the 
subjects by phone and give a short introduction to the investigation and go over the inclusion 
and exclusion criteria. 
If the subjects do not meet the inclusion criteria or meet the exclusion criteria, this will be regis-
tered at the Subject Screening Log.  
Subject Infor-
mation Form 
If subjects are eligible and interested in participating, then written information about the investi-
gation (subject information) will be sent to the subjects to ensure that they are given the oppor-
tunity to read about the investigation before a possible informational visit, and so that they can 
prepare any possible questions they may have. The subject information provides information to 
subjects about how to contact the investigator or a representative thereof, or a representative 
of the sponsor (name, telephone number and e-mail address), if they wish to learn more about 
the study. 
First visit  
Information visit 
If an eligible subject is interested in participating after the first contact, a visit will be arranged in 
a room reserved to ensure privacy and quiet surroundings at the investigators clinic/depart-
ment. When arranging the visit, it will be ensured, that the subject has received the Information 
Form prior to the visit. The subjects will receive both written and verbal information about the 
possibility of bringing a companion to the informational visit and to any possible subsequent 
visits. 
See section 13 for information to be given to the subjects, as well as the informed consent pro-
cess. 
Enrolment and in-
clusion visit (V0) 
The subjects have the right to wait 24h before deciding on participation. If/when the subject de-
cides to participate he/she will be asked to sign the relevant forms (see section 13). If a subject 
so desires, and it is certain that it is understood what the investigation entails and the relevant 
forms have been signed the subjects are considered enrolled in the investigation. 
 
The first ten subjects will be enrolled at the Coloplast Humlebæk Site DK001 (Sponsor). When these ten sub-
jects have completed the first 7-1/+3 days with the test product and completed the safety visit (V3) in proper 
compliance and with no unexpected events related to the test product, all following subjects can hereafter 
continue with enrolment and Test Period 2 at all sites.  
The subjects, at other sites than DK001, will be invited for the Test Visit 1 during week 49-51 (December 2018) 
and for their Test Visit 2 during week 1 and 2 (January 2019), due to Christmas holiday, follow-up logistics and 
planning purpose. Hereafter, subjects will have 7-1/+3 days between their following visits.  
The coordinating clinical manager will have close contact to each site during the recruitment period. The in-
vestigator at each site will notify the clinical manager of all planned inclusion visits and whenever a subject is 
enrolled. This will be done by mail and be site registration in a sheet for this purpose. When the coordinating 
clinical manager is aware that 25 subjects have been included, the recruitment will stop. Subjects who have 
been informed of the investigation and are reflecting on their participation may be included within the first 24 
hours hereafter. 

 
 
 
Page 31 of 67 
 
CONFIDENTIAL 
 
 
Enrolment period will be between 12-39 days for Test Period 1 and 28-4/+12 days for Test Period 2. Site should 
however ensure that the visit windows are adjusted for the subjects to be terminated at last LSLV, at the latest. 
6.3.4. Subject withdrawal criteria 
The subject is allowed to withdraw from the investigation at any time for whatever reason without any conse-
quences for their future treatment outside the clinical investigation. Investigator may withdraw a subject from 
the investigation at any time if they judge it to be the subject’s interest. 
The investigator must withdraw a subject from the investigation due to: 
• Non compliance with the CIP impacting the scientific integrity of the investigation  
• If subject’s safety and wellbeing is compromised by further participation. 
 
Withdrawn subjects will not be replaced by new subjects. 
A subject who is withdrawn from the investigation, for any reason, will be encouraged to contact the investigator 
if problems arise that the subject believes are related to the clinical investigation. Subjects who have not ex-
perienced any adverse events will not be followed up. For subjects who experience adverse events, see sec-
tion 14.  
6.3.5. Point of enrolment 
A subject is considered enrolled in the investigation when the written informed consent is obtained. The ex-
pected duration for each subject is described in section 6.1. 
6.3.6. Total expected duration of the clinical investigation 
The dates below are approximate and no subjects will be enrolled before all required approvals have been 
obtained. Changes greater than ± 3 months will be notified to EC and regulatory authorities. 
Activity 
Estimated time 
First subject enrolled 
November 2018 
Last subject enrolled 
December 2018 
Last subject completed (LSLV) 
February, 12th, 2019 
Final Report 
February 2020 
 
6.3.7. Total number of subjects 
Based on sample size calculations (see section 7.2) 21 one-piece users should be included in this investiga-
tion. However, to take potential drop-out into account a total of 25 one-piece users will be included (allocated 
a subject number). 
6.4. Procedures 
6.4.1. Clinical investigation-related procedures 
See section 6.4.4 Flow-chart for a more detailed overview of the clinical investigation-related procedures at 
visit and 6.4.5 for a more detailed overview
 
 

 
 
 
Page 32 of 67 
 
CONFIDENTIAL 
 
 
Site visits 
Before initiation of the clinical investigation, sponsor must be provided with key personnel’s signed and dated 
curriculum vitae (not more than two years old) to verify their qualifications. Key site personnel are those, who 
conduct the clinical investigation and obtain subject data. Also, the sponsor will ensure that all site personnel 
are trained in the investigation procedures, how to complete the CRFs, procedure for reporting an adverse 
event and serious adverse event (how, when, to whom), and who to contact in case of emergency related to 
the investigational device.   
Visit 0 (Information and Inclusion visit) 
If a potential subject is interested in participating after the first contact, a visit (visit 0) will be arranged in a room 
reserved to ensure privacy and quiet surroundings at the investigators clinic/department. When arranging the 
visit, it will be ensured, that the subject has received the Subject Information Form prior to the visit. The subjects 
will receive both written and verbal information to ensure that the subject understand what was read and ex-
plained and can freely agree to participate in the investigation. The subject will, beforehand, also be informed 
about the possibility of bringing a companion to the informational visit and to any possible subsequent visits. 
During the visit the Investigator or delegated personnel will provide oral information about the investigation 
based on the Subject Information Form. The subjects have the right to wait 24h before deciding on participa-
tion. The information visit and the Visit 0 can be the same day. 
If/when subjects decide to participate they will be asked to sign the Informed Consent Signature Form and 
other relevant forms (see section 13). If a subject so desires, and it is certain that it is understood what the 
investigation entails and the relevant forms have been signed the subjects are considered enrolled in the 
investigation. Enrolled subjects that fulfils the in- and exclusion criteria are allocated a subject number, and 
hereafter demographics, baseline data and concomitant medications is recorded by Investigator or delegated 
personnel.  
Visit 0 and visit 1 can be combined.  
 
Test visits (V1, V2, V4, V5 and V6) 
During test visit 1, the subject will be introduced to the clinical app on how to complete the questionnaires and 
take pictures. At visit 2 the test products will be handed out. At this visit the subjects will be trained according 
to the IFU, in preparation of the product (e.g. hole size), preparation of skin before application (e.g. cleaning 
and wiping), application of product (e.g. correct position and applying pressure to the baseplate), removal of 
product and storage of the product.    
At each test visit objective skin measurement will be done, the product changed at the visit will be collected for 
further analysis, pictures of cut product will be taken, stoma condition, skin condition and safety endpoints will 
be registered. At test visit 2 and 6 questions regarding feeling of security, handling, leakage scale and quality 
of life will be completed by subject. An output sample will be collected for further analysis at test visit 1 and 2. 
The output samples and products changed at the visit will be stored in a separately CP300 allocated freezer 
at site, and send on an ongoing basis to Coloplast A/S, Humlebæk, Denmark. The samples of output will not 
be stored longer than it takes to collect and analyse the samples. The sample will be destroyed directly after 
analysis.   
At test visit 6 questions about product preference will be completed by subject. 
Product change  
At every product change the subjects will record reason for change, pain/discomfort, skin condition and use of 
accessories. Wear time of the product will be calculated from the time for product change registered in the 
app.   

 
 
 
Page 33 of 67 
 
CONFIDENTIAL 
 
 
At every product change the subject will be asked to take a picture of the back side of the changed products 
(leakage), the peristomal skin and the cut product to be applied. 
 
 
Subjects will also be informed about the possibility to contact a Coloplast nurse during the investigation, to 
ensure questions and experiences addressed answered properly. This will be a secondary contact person in 
addition to the study nurse at site.  
Safety follow-up 
To follow safety closely during the investigation, a safety visit (V3) is planned after one week of wearing the 
test product. The safety visit will, when logistically possible, be conducted by Sponsor at site, supported by 
Investigator or study nurse. The subjects will be asked about all experiences with their stoma during the inves-
tigation and other safety endpoints, following the safety interview guide (see Appendix 4). In addition, the 
product changed at the visit will be collected for further analysis.  
To follow safety further, Sponsor might also wish to be presented at subjects’ test visits. Sponsor will observe 
during the test visit and might ask the subject questions about experiences with their stoma during the inves-
tigation and other safety endpoints, following the safety interview guide (section20.4). 
Interview 
The subjects will be offered to participate in two interviews. The interviews will be about the subjects experi-
ence with the test product and might include a change of product. The subjects can participate in the investi-
gation without being interviewed. The interviews, or relevant parts, might be video recorded, tape recorded or 
photos might be taken. The subjects will be asked for consent, but can participate in interviews without com-
pleting video, tape or photos.  
 
- 
Interview 1: at test visit 6 (at site) or within 14 days after termination (at home). If the interview is 
part of the test visit, Sponsor will be present during the test visit. At first, they will ask the subject un-
probed questions to get their immediate response to the product. Hereafter, the subject can continue 
the test visit as usual. At the end of the visit, the interviewer will interview the subject following the 
interview-guide. If the subject has consented to photo, video and/or tape recording the interviewer 
might do so during relevant parts of the interview and test visit. 
  
- 
Interview 2: a follow-up visit at home within three months after last patient out.  
 
The information needed from interviews are estimated to be covered by up to 6-10 subjects, but all will be 
asked if they would like to participate, if more than ten are needed. If fewer than six subjects agree to be in-
terviewed, we will settle for the number that have agreed. This has been decided since the main endpoints 
are covered in the CRF. It is known from experience that it is not always possible to perform all the inter-
views face-to-face due to logistics. In order, not to lose important information about the tested products, inter-
views may be by telephone / video call, in cases the interviewers cannot be present at the visits.  
 
In addition, the study nurses and/or investigator may be interviewed during and/or within three months after 
termination of the investigation.  
All interviews will be performed by Sponsor following an interview guide (Appendix 5). 
Follow-up after the investigation 
Subjects who do not have an ongoing AE, or are not participating in the second interview are not followed up 
on after termination of the investigation. For ongoing AEs at investigation termination, please see section 14.4. 
All subjects are encouraged to contact the Investigator or the associated Coloplast nurse after termination of 

 
 
 
Page 34 of 67 
 
CONFIDENTIAL 
 
 
the investigation, if they experience problems that they believe are related to their participation. This is to 
ensure that any device-related events are documented and to safeguard the subjects’ health.  
6.4.2. Activities performed by sponsor representatives 
Sponsor or representative hereof (CRA/Monitor) will make a selection visit, site monitoring visits and site close 
out visit. At the selection visit Sponsor or representative hereof will ensure that the Investigator is qualified to 
conduct the investigation, is keen to participate, and has the time, resources and location to run the investiga-
tion. When the site has been selected to participate in the investigation, the Sponsor or representative will be 
responsible for: 
• Training of investigator and delegated personnel in the investigation procedures, how to complete the 
CRF and how to report possible safety issues to Sponsor. All training will be documented by site and 
sponsor signing the Training Log. However, with any change of staff at site after the initiation, Princi-
ple Investigator is responsible for the training of the new staff. 
• Identify and contact possible investigation subjects from Coloplast A/S's ostomy user database in 
Denmark and Sweden by letter, email or advertisement 
• Support during the recruitment process 
• Support during the test periods 
• Monitor site as described in section 6.5 and the Monitoring Plan 
• Perform the interviews  
• Collect and analyse data 
• Equipment for measurements 
• Comparator, test products, stoma scissors etc. 
• Other equipment used during the visits (gloves, napkins, alcohol-gels etc.) 
 
6.4.3. Foreseeable factors that may compromise the outcome / results 
Use of ostomy accessories may influence the actual performance of the test products. It is not known if acces-
sories will have a “positive” or “negative” influence on the product performance.  Subjects are asked not to use 
adhesive remover during the investigation as adhesive remover residues on the skin can interfere with the 
objective skin measurements such as TEWL. In addition, subjects who usually use a ring/seal will also be 
asked not to use these accessories during the investigation. This is to be able to understand the performance 
of the test products. However, for ethical reasons it is allowed that subjects that experience problems with 
removing the test products or leakage can use adhesive remover and rings/seals, respectively.  
Some subjects enter the study using other accessories to minimise leakage under the baseplate. When this is 
part of the subject’s standard care procedure these subjects may continue to use the accessories, they used 
when entering the study if they use the same accessories throughout the entire study period. It is important 
that a subject uses the same kind of accessories when testing the products as this gives the best conditions 
for comparing the performance of the products. 
 
 

 
 
 
Page 38 of 67 
 
CONFIDENTIAL 
 
 

 
 
 
Page 39 of 67 
 
CONFIDENTIAL 
 
 
 
6.4.6. Randomisation Procedure  
Not applicable since no randomisation will take place 
6.4.7. Blinding 
The investigation is not blinded because the test product and SenSura® Mio are visible different from each 
other. If the subjects have a preconceived attitude to the test products or SenSura® Mio bias could occur for 
all subjective parameters. 
 
6.4.8. Case Report Forms 
The CRFs are printed and supplied by Sponsor. The CRFs are printed on NCR paper in order to have one 
copy for investigator and one copy for sponsor (original copy). A CRF is provided for each subject. It is the 
responsibility of the Investigator that all data are entered promptly and correctly.  
Each CRF have printed instructions for completion.  
The CRF will be filled in by the subject and by the investigator/relevant staff, who have signed the Site Per-
sonnel Signature and Delegation List and Clinical Investigation Training Log. It will be the responsibility of 
investigator that all measurements and observations are correctly noted with a pen (permanent writing utensil) 
in the CRF.    
The Case Report Forms for each subject will be divided in three parts: 
• 
Investigator Binder; Investigators registration of inclusion and exclusion criteria, baseline data, skin 
measurements, stoma condition, skin condition and safety endpoints at visits.  
• 
Subject questionnaire; Subjects registration of feeling of security, handling, quality of life, leakage 
scale questionnaire and preference at visits. 
• 
Subject diary 
 and paper); Subjects completion of reason for change, skin condi-
tion, use of accessories, pain/discomfort, and subject pictures will be registered
 
  
Qualitative endpoints (interviews) will be registered as notes, and will not be part of the CRF. Other endpoints 
than the above mentioned will be registered directly from source to the data base. 
Any correction in the CRF must be clearly signed and dated by authorised site personnel. The entry corrected 
must be crossed out so that the entry is still legible. 
Example 1: 
 
 
 
Example 2: 
 
 
 
Figure 4 Two examples of how to make corrections in the CRF 

 
 
 
Page 40 of 67 
 
CONFIDENTIAL 
 
 
The investigator will keep a separate list with the subject ID numbers, names and addresses in a locked room. 
Only data referred to in this clinical investigation plan will be recorded in the CRFs.   
CRFs will be collected and send to site continuously by Monitor after completed monitoring and sign of by 
Investigator. 
 
 
 
6.4.9. Concomitant treatment  
Concomitant treatment, including medication, will be registered in the CRF.  
 
Subjects are not allowed to use ring/seals, unless they can’t do without.  
See also section 6.4.3 for foreseeable factors.  
6.5. Supplementary material and equipment 
The Sponsor will provide the sites with supplementary materials for this investigation. Supplementary materials 
would be: 
• 
CRFs 
• 
 
• 
Skin measurements equipment 
• 
Camera with lightbox 
• 
Camera 
• 
Subject toilet bags including stoma guide, scissor, pen, disposal bags etc. 
• 
Nurse kits including disposal bags, gloves, gauze, disinfection gel etc. 
 
6.6. Monitoring Plan  
Coloplast representatives will review data centrally to identify potential issues to determine a schedule of on-
site visits for targeted review of study records. 
 
 
 
 
For safety reason the Coordinating Investigator, a delegate hereof or equivalent competent Coloplast repre-
sentatives will monitor the subjects’ stoma if relevant by visiting the sites when subject visits are performed. 
Coloplast representatives must be allowed to visit all study site locations periodically to assess the data quality 
and study integrity. On site, they will review Study CRFs and directly compare them with possible source 
documents, discuss the conduct of the study with the investigator, and verify protocol compliance, and that the 
facilities remain acceptable. CRF pages and/or subject files at site may serve as the source documents.  
Signed ICF, Subjects identity any AE/SAE and Concomitant Medication will be monitored 100 %. All entered 
data in the CRF will be reviewed for completeness and for relevant purpose. 

 
 
 
Page 41 of 67 
 
CONFIDENTIAL 
 
 
When a site has been visited for monitoring a monitoring report is written to document the status of the study 
at site and to ensure the rights, safety and well-being of the subject are protected, and that all data obtained 
by the site is consistent with the protocol. 
Detail for the monitoring visits are described in the Monitoring Plan. The Monitoring Plan explain the type of 
visit relevant for the study and why they are performed, the frequency of the monitoring visits, and the timeline 
for the Reports. 
The study may undergo audit and/or inspection, which allow access to CRFs, source documents, other study 
files, and study facilities. The audit/inspection will be announced when relevant. Audit reports will be kept 
confidential. 
The investigator must notify Coloplast promptly of any inspections of the study scheduled by regulatory au-
thorities, and forward copies of inspection reports to Coloplast. 
6.6.1. Source data verification 
The Monitor will ensure proper access to all Source Data due to local regulations. 
A Source Data Specification Form, detailing the location of all source data (Paper CRF, Subject diary
 
 Interviews incl. video/tape recordings and photos (if applicable)) for each data point, shall be com-
pleted at the initiation visit for the investigational site to document what is source data for the data collected at 
each site. This Source Data Specification Form must be signed and dated by the Investigator and the Monitor 
to verify the agreement between the two parties and when this Source Data Specification Form was agreed.  
 Source data verification must be performed, -per monitoring plan for all 25 expected enrolled subjects. 
 
For all subjects, the following will be 100% source document verified: 
• 
Informed Consent Forms 
• 
Inclusion – and exclusion criteria 
• 
Letter of Authority Form 
• 
Declaration of Contraception Form 
• 
Inclusion number / 
  
• 
Primary and explorative endpoints 
• 
All protocol-defined adverse events (AE), ADE, SAE, SADE 
 
Furthermore, the following will be reviewed/monitored for completeness and consistency: 
• 
All Data entered in the CRF 
• 
Deviations 
• 
Subject diary 
• 
Device Accountability 
 
At the discretion of the monitor and in consultation with the Clinical Manager additional data may be reviewed 
in case of quality concerns such as:  
• 
Non-compliance and data quality issues 
• 
Number of and/or type of unreported adverse events observed during source data verifica-
tion 
• 
Number of and/or type of deviations 
• 
Number of unresolved queries/data clarification forms 
 

 
 
 
Page 42 of 67 
 
CONFIDENTIAL 
 
 
At the completion of the monitoring visit, the monitor will meet with the investigation coordinator and/or Principal 
Investigator, if necessary, to review and discuss the monitoring findings. In addition, the monitoring accom-
plishments and findings will be reviewed by the Coloplast study team and Clinical manager or designee to 
assess corrective action measures as needed. 
 
The Informed Consent forms – and the Letter of Authority form - and compliance with the inclusion and exclu-
sion criteria, as well as all AEs, are verified 100% for completion at the correct time. All CRFs are monitored 
for incomplete data and incorrect data. Furthermore, all events that occur during the investigation period are 
registered in the CRF and followed up by the Investigator. 
Only the Investigator, delegated site personnel and representatives of the sponsor will have access to all 
CRFs. The subjects will have access to their own CRF (however, see also section 12.3).   
Representatives of the sponsor are: Data manager, Coordinating Clinical Manager, Clinical Managers, Sci-
entific Manager and the medical adviser. In relevant situations, the data responsible can allow others to ac-
cess the CRFs.  
 
6.6.2. Other methods for data quality assurance 
The sponsor, sponsor’s representative and/or investigational sites may be inspected by competent authori-
ties or their representatives and likewise may be audited per Coloplast’s internal quality audit plan and proce-
dures. The investigator allows access to source data, medical records and other relevant documents for this 
study both for monitoring, audit and/or inspections from the Ethics Committee and authorities from other 
countries.   
 
 

 
 
 
Page 43 of 67 
 
CONFIDENTIAL 
 
 
7. Statistical considerations 
7.1. Statistical design, method and analytical procedures  
Definition of analysis populations: 
The ITT population (full analysis set) will be constituted by all included subjects who:  
• 
Have provided valid informed consent 
• 
Have valid information for at least one of the endpoints 
Invalid individual data points may be omitted from analysis even though the corresponding subject is part of 
the ITT population. Any exclusion of data points will be documented.  
The Safety population (basis for presentation of AEs) will constitute by subjects who have given informed 
consent.  
A formal PP population is not planned due to the explorative nature of the investigation. Considering the data 
obtained it might however be considered to make additional explorative analyses based on a subset of the ITT 
population. 
Analysis of the primary endpoint 
The primary endpoint is TEWL measured at 4 spots (up, down, left and right) around the stoma in the inner 
circle at steady state. For each subject 3 repeated measurements will be made for each spot and at each test 
visits at site for products worn in the 2 test periods. The comparison in TEWL between the 2 products is used 
to evaluate the primary objective of the investigation.  
A linear mixed model will be applied to the log transformed TEWL data. The model will include a fixed effect 
of product (comparator and test product). Further the model will include:  
• 
a random effect of subject 
• 
a random interaction effect of product and subject 
• 
a random interaction effect of spot in the inner circle and subject  
• 
a random interaction effect of product, spot and subject 
• 
a random interaction effect of product, visit and subject 
• 
a random interaction effect of product, spot, visit and subject.  
  
If the assumption of steady state for the test product is not reached after 2 weeks, the analysis can be per-
formed with only test product data from visit 5 and 6 (3 and 4 weeks). 
From this model the difference in TEWL between products will be estimated.  As TEWL is analysed log trans-
formed the estimated differences on log-scale will be back-transformed to the original scale as estimated ratios. 
Analysis of the exploratory endpoint 
 
 

 
 
 
Page 46 of 67 
 
CONFIDENTIAL 
 
 
7.8. Deviation(s) from statistical plan 
Any deviations from the statistical plan will be documented in the clinical report. 
8. Data management 
8.1. Data review, database cleaning, and issuing and resolving data queries 
Data management and statistical analyses is carried out by Medical Affairs, Coloplast A/S.  
To ensure correct data entry, data is entered twice (double data entry). Data management is responsible for 
control of data consistency and also for completeness of data from each subject. 
Discrepancies are listed in Data Query Forms (DQF), and the Investigator is responsible for solving these 
promptly. When all DQFs are solved the database is locked and the final statistical analyses are performed.  
8.2. Verification, validation and securing of electronic clinical data systems 
EXPeRT Data Management, version 5.0.05 system delivered by OmniComm Systems Inc. is used for data 
management. The system is designed to be compliant with the requirements of 21 CFR part 11. It is a validated 
data management system allowing only qualified and trained personnel to enter the system.   
For collection of the subject diary data, Coloplast A/S uses a newly developed clinical trial application devel-
oped by “Blue Fragment”. 
 
8.3. Data retention 
The sponsor file must be archived for a minimum period of 5 years after the final clinical investigation report 
has been signed.    
All investigation site documents must be archived for a minimum period of 5 years after the final clinical inves-
tigation report has been signed. The monitor is responsible for informing the investigator and the CTM if this 
period should be longer for their sites according to local regulation. 
 

 
 
 
Page 47 of 67 
 
CONFIDENTIAL 
 
 
9. Amendments to the CIP 
Any significant changes to the CIP are:  
• Agreed between sponsor, PI(s) and the coordinating investigator. 
• Justified in a statement included in the amended section and the version number and date of amendment 
must be documented. 
• Registered in the Change Log. 
• Notified to or approved by the EC before implementation 
• Notified to or approved by the regulatory authorities before implementation 
 
Example of significant change: Changes of inclusion criteria, endpoints or assessment methods.  

 
 
 
Page 48 of 67 
 
CONFIDENTIAL 
 
 
10. Clinical Investigation Plan deviations 
10.1. Deviations 
Deviations to Clinical Investigation Plan occurs when the activities during the clinical investigation diverge from 
the Ethic committee approved investigation plan.   
A deviation does not increase risk or decrease benefit or; does not have a significant effect on the subject's 
rights, safety or welfare; and/or on the integrity of the data. 
Examples of deviations: 
• Vital signs obtained prior to informed consent 
• Partly completing required tests 
The Investigator is not allowed to deviate from the Clinical Investigation Plan unless under emergency circum-
stances and to protect the rights, safety and well-being of the subject(s).  
Deviations must be reported to sponsor and deviations affecting the scientific aspect of the investigation or the 
safety of the subject are reported to the Ethical Committee by sponsor. 
If any deviations and/or violations to the investigation plan are detected, the Clinical Manager will complete a 
Deviation/Violation Form and inform/discuss with the Principal Investigator immediately. 
10.2. Violations 
Violations to the Clinical Investigation Plan occurs when there is divergence from the Ethical Committee ap-
proved investigation plan (a deviation) that also: 
• Reduces the quality or completeness of the data 
• Impacts a subject’s safety, rights or wellbeing 
• Affects the scientific integrity 
 
Examples of violations: 
• Inadequate informed consent 
• Enrolment of subjects not meeting the inclusion / exclusion criteria 
• Initiation of study procedure prior to completion of informed consent  
• Unreported SAE’s 
• Repeated deviations of the same nature 
• Falsification 
 
If any deviations and/or violations to the investigation plan are detected, the Clinical Manager will complete a 
Deviation/Violation Form and inform/discuss with the Principal Investigator immediately. 
In case of continued or repeated violations affecting the scientific aspect of the investigation or the subjects’ 
rights, safety and well-being sponsor will disqualify the PI from further participation in the investigation. 
The Clinical Manager must report all violations detected during a monitoring visit in the Periodic Monitoring 
Report. 
 
 

 
 
 
Page 49 of 67 
 
CONFIDENTIAL 
 
 
11. Device Accountability 
All access to the investigational devices used in the clinical investigation is controlled by storage procedures 
and device accountability logs as described below. The investigational devices must only be used in this clinical 
investigation and only according to the Clinical Investigation Plan. 
Sponsor keeps a device accountability log that states the physical location of all investigational devices from 
shipment of investigations devices to the investigational sites until return of or disposal. 
The Investigator or a delegate hereof keeps records documenting the receipt, use and return and disposal of 
the investigational devices, which includes: 
• Date of receipt. 
• Identification of each investigational device (batch no./serial no./uniqe code). 
• The expire date, if applicable. 
• Subject identification. 
• The date on which the investigational device was distributed to the subject. 
• The date on which the investigational device was returned/explanted from the subject 
• The date of return unused, expired or malfunctioning investigational devices 
 
 
 

 
 
 
Page 50 of 67 
 
CONFIDENTIAL 
 
 
12. Statement of compliance 
The clinical investigation is conducted in accordance to: 
• Ethical principles that have their origin in the Declaration of Helsinki, 1964, Last amended at the 59th WMA 
General Assembly, Seoul, October 2008. 
• MDD 93/42/EEC as amended by Directive 2007/47/EC (commonly known as the Medical Device Directive). 
• ISO 14155:2011 “Clinical Investigation of medical devices for human subjects – Good clinical practices”. 
• Any applicable regional or national regulations  
 
12.1. Ethics committee and regulatory authorities 
The CIP and/or other relevant documents are submitted to the appropriate EC(s) and regulatory authorities. 
This clinical investigation will not begin until the required approval from the EC and regulatory authorities have 
been obtained. Any amendment to the protocol will be submitted to the same EC(s) and regulatory authority. 
Sponsor will notify the relevant regulatory authority and EC(s) concerned of the end of the clinical investigation. 
Approval from the Danish Protection Agency is not necessary as this clinical investigation is done by a private 
company and therefore is exempted from notification. 
12.2. Data protection 
All information collected during this investigation is owned by Coloplast and is kept strictly confidential. Sub-
jects are identified by an investigation number and the investigation monitor has access to subjects’ notes/doc-
umentation for source data verification. Monitoring and monitoring findings will be documented in a report to 
explain and document that the rights and well-being of the subjects are protected, that the reported data are 
accurate, complete and verifiable from source documents, and that the conduct of the investigation is following 
the currently approved Clinical Investigation Plan (CIP), including amendments, and with the applicable regu-
latory requirements. The reports have no subject identification and are kept confidential during the conduct of 
the investigation and during archiving for 6 years. Subjects remain anonym for data analysis, as the data is 
blinded correspondingly in the data analysis. 
Should the investigation require future review, relevant ethics committees and Coloplast Internal Audit per-
former will be allowed access to all relevant information for audit purposes.  
 
 
 
  
Coloplast complies with applicable data privacy law, including the EU General Data Protection Regulation 
(“GDPR”). Under GDPR the legal basis for Coloplast’s collection and use of the personal information is for the 
purpose of analyzing samples, and all data collected in this clinical investigation to innovate and improve Colo-
plast’s stoma products. 
Coloplast protects all personal information and will only allow it to be used for the mentioned purposes related 
to only this clinical investigation.  
Each subject is entitled to get access to all the data and to have rectified any inaccurate data Coloplast is 
processing about the subject. All data are collected based on the consent each subject has given when being 
eligible and enrolled in the investigation. The subject is entitled to withdraw any such consent at any time, and 

 
 
 
Page 51 of 67 
 
CONFIDENTIAL 
 
 
Coloplast will then cease to use such personal information for further innovation and improvement of stoma 
products. The already data collected and handled in the investigation will not be retired. 
For further information please see Coloplast’s Global Privacy Notice (www.coloplast.com/global/privacy-no-
tice). 
12.3. Indemnity 
 
 
 
  
 
 
 
 
 
 
 
 
 
12.4. Financial conditions 
The clinical investigation is initiated and sponsored by Coloplast A/S. 
 
Coloplast A/S will pay all investigators involved in the clinical investigation for their time and resources spent 
on site to comply with the Clinical Investigation Plan. All financial agreements with the investigation sites in-
volved in the clinical investigation will be specified in a sponsor investigator agreement. All investigator partic-
ipating in this clinical investigation are employed at private clinics conduct clinical investigations. 
 
 
  
 
 
 
 
 
13. Informed consent process 
Written informed consent is obtained at visit 0 (inclusion visit) from all subjects participating in the investigation 
after thorough written and verbal information. The informed consent process takes place in a room reserved 
for ensuring privacy and quiet surroundings at the investigator's department. The subjects will receive both 
written and verbal information about the possibility of bringing a companion to the visit and to any possible 
subsequent visits. 
The information is given by the investigator or a delegate hereof in the subjects’ native non-technical language. 
Each subject will be fully informed about the aim of the investigation, procedures, potential risks or inconven-
iences and/or expected benefits and have a minimum of before deciding on participation. The subjects will be 

 
 
 
Page 52 of 67 
 
CONFIDENTIAL 
 
 
informed that their participation is voluntary and that they may leave the investigation at any time, without this 
having any influence on their further treatment. 
 
If the subject decides to participate in the clinical investigation, the subjects will be asked to sign a Consent 
Form, in which the subject consent to participate under the circumstances described in Subject Information 
Form.  
When signing, the Consent Form the subject accept to pass all data and information, received from the subject 
by the investigation physician or investigation staff during the investigation, to Coloplast A/S, and/or repre-
sentative hereof, relevant competent authorities and to a third party including those in countries outside the 
European Union. The consent for access to the parts of the subjects medical records, that are relevant to the 
investigation, covers the investigation period and an additional five years. This is to verify that collected data 
are accurate, and that the investigation is being carried out as planned and in agreement with the current laws 
and regulations.  
All parties involved in this clinical investigation, also including relevant authorities, are governed by confidenti-
ality about the information, they might be aware of. All collected data and information will be kept and stored 
confidential and in an anonymous form by Coloplast A/S who is data responsible. The investigation physician 
will use an investigation subject ID number to identify the subject.  
 
In addition, the subject will be asked to sign the following documents: 
• 
Subjects must also sign a power of attorney, which permits the sponsor and the authorities to gain 
access to data registered as part of this investigation, including their medical records if necessary.  
 
• 
Woman in the childbearing age, will be asked to sign a Declaration of Contraception Form, which 
confirms that the subject do not plan to get pregnant during the investigation period, and that the 
subject will use birth control during the investigation. 
 
• 
In addition, the subject will be asked if they would like to participate in two interviews, as described 
elsewhere in this protocol. It is voluntarily to participate in interviews, and the subject can participate 
in the clinical investigation without being part of the interviews. 
 
• 
If the subject consent to interviews, the subject will be asked to consent to have pictures taken, video 
or tape recorded during parts or during the whole interview. It will not be possible to identify the sub-
ject from the pictures, video and tape records taken, and the participation is voluntarily. The subject 
can participate in the two interviews without having any pictures, video or tape records taken. 
 
The informed consent signature form and the above-mentioned form includes personally dated signatures of 
the subject and the Principle investigator or a delegate hereof responsible for conducting the informed consent 
process. A copy of all signed forms will be provided to the subject. 
 
If new information is to be given during the investigation, sponsor will inform the investigators, and the new 
information is given to the subjects by the investigator. If new information becomes available that can signifi-
cantly affect a subject’s future health and medical care that information will be provided to the subject in writ-
ten form. Clinical Manager is responsible for writing the information and providing it to investigators that will 
further provide it to the subjects. If applicable, all affected subjects shall be asked to confirm their continuing 
informed consent in writing. 
This procedure also applies to informed consent obtained from a subject’s legal representative. The proce-
dure cannot waive the subjects’ legal rights. 
 
 
 

 
 
 
Page 53 of 67 
 
CONFIDENTIAL 
 
 
 
14. Adverse events, serious adverse events and device deficiencies 
 
Figure 5: Adverse event flow 
14.1. Adverse events  
14.1.1. Adverse event 
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users or other parties, whether or not related to the med-
ical device(s), or the procedures involved. This could include events such as headache or dizziness. 
14.1.2. Adverse device effect 
An adverse event, which is related to the use of the investigational medical device, is an adverse device effect, 
and should be marked as related or possibly related on the adverse event form. 
The definition of an adverse device effect includes any event resulting from insufficiencies or inadequacies in 
the instruction for use, malfunction of the device, use error or from intentional misuse of the device. 
Table 6 lists anticipated adverse device effects that may occur. 
 

 
 
 
Page 54 of 67 
 
CONFIDENTIAL 
 
 
Table 6 Anticipated adverse device effects and their likely incidence rates 
ANTICIPATED ADE 
Peristomal skin irritation (incl. mechanical trauma) 
Allergic peristomal skin irritation (dermatitis) 
Irritated stoma (incl. strangulation of stoma) 
 
The definition of an adverse device effect includes any event resulting from insufficiencies or inadequacies in 
the instruction for use, malfunction of the device, use error or from intentional misuse of the device. 
Please see section 4.2 for an overview of anticipated risks.  
Temporary redness upon removal of the baseplate is not considered to be an adverse device effect. However, 
an abnormal development in the intensity or duration of redness should be considered an adverse device 
effect. A development in redness after removal of the baseplate is considered abnormal, when the intensity of 
redness is not decreased after five-ten minutes after the baseplate has been removed. 
14.2. Device deficiency  
A device deficiency is the inadequacy of the investigational medical device with respect to its identity, quality, 
durability, reliability, safety or performance. This includes malfunctions, misuse or use errors and inadequate 
labelling. 
Primary and explorative endpoints that are measured during this investigation will not be required to be re-
ported as device deficiencies.  
14.3. Serious adverse events  
14.3.1. Serious adverse event 
A serious adverse event is an adverse event that: 
• Led to death, 
• Led to a serious deterioration in health of the subject that either resulted in: 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, or 
3) required in-patient hospitalization or prolongation of existing hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to 
a body structure or a body function. 
• Led to fetal distress, fetal death or a congenital abnormality or birth defect. 
 
This includes device deficiencies that might have led to a serious adverse event if: 
• Suitable action had not been taken, or 
• Intervention had not been made, or 
• Circumstances had been less fortunate. 
These are handled under the serious adverse event reporting.  
Planned hospitalization for a pre-existing condition, or a procedure required by the CIP, without serious dete-
rioration in health, is not considered a serious adverse event. 

 
 
 
Page 55 of 67 
 
CONFIDENTIAL 
 
 
14.3.2. Serious adverse device effect 
A serious adverse device effect is an adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
14.3.3. Anticipated serious adverse device effect 
Anticipated serious adverse device effect is any event that by its nature, incidence, severity or outcome has 
been previously identified in the risk analysis report. 
14.3.4. Unanticipated serious adverse device effect 
An unanticipated serious adverse device effect is a serious adverse device effect which by its nature, inci-
dence, severity or outcome has not been identified in the current version of the risk analysis report. 
14.4. Medical care of subjects 
Principal investigator shall ensure that adequate medical care is provided to a subject experiencing an adverse 
event during and after participation in the clinical investigation. All serious adverse events will be followed until 
a resolution is addressed. 
 The current status of all ongoing adverse events is documented during site close-out. 
14.5. Reporting and timelines 
14.5.1. Investigators reporting responsibilities 
PI must assess all (S)AE`s that occur at his/her site. 
• All serious adverse events and serious adverse device effects must be reported to Sponsor immediately, 
but no later than three calendar days, after Investigator or other site personnel’s awareness of the event. 
When reporting the SAE the relationship to the test product shall be described whether the event is consid-
ered:  
o 
Not related, the event has no temporal relationship with the use of the test product or the  
procedures.  
o 
Unlikely related, the relationship with the use of the test product seems not relevant and/or the 
event can be reasonably explained by another cause, but additional information may be obtained. 
o 
Possible related, the relationship with the use of the test product is weak but cannot be ruled out 
completely. Alternative causes are also possible (e.g. an underlying or concurrent illness/ clinical 
condition or/and an effect of another device, drug or treatment). Cases were relatedness cannot be 
assessed or no information has been obtained should also be classified as possible. 
o 
Probable related, the relationship with the use of the test product seems relevant and/or the event 
cannot reasonably be explained by another cause, but additional information may be obtained.    
o 
Causal relationship, the event has a temporal relationship with the test product use/application or 
procedures.  
 
• A device deficiency that could have led to a serious adverse event but did not because suitable action was 
taken, intervention had been made or because of fortunate circumstances should be reported to Sponsor, 
immediately, but no later than three calendar days, after Investigator or other site personnel’s awareness of 
the event. 
• New findings and/or updates in relation to already reported serious events should also be reported to Spon-
sor within three working days. 

 
 
 
Page 56 of 67 
 
CONFIDENTIAL 
 
 
• Device deficiencies and all adverse device effects must be reported to sponsor within 10 days.  
All above events must be reported by use of the relevant adverse event/serious adverse event/device defi-
ciency form. 
All above events must be reported by use of the relevant adverse event/serious adverse event/device defi-
ciency form. 
Please report to: 
Clinical-studies@coloplast.com  
 
 
 
 
 
 
 
 
 
 
14.5.2. Sponsors reporting responsibilities 
It is the responsibility of sponsor to ensure that the following are reported to national regulatory authorities 
immediately and ethics committee (if required), but no later than seven calendar days following the date of 
awareness by Sponsor.  
• All serious adverse events. 
• All serious device effects.  
• All device deficiencies that could have led to serious adverse events but did not because suitable action 
was taken, intervention had been made or because of fortunate circumstances. 
• New findings and/or updates in relation to already reported events. 
 
If the serious adverse event results in imminent risk of death, serious injury, or serious illness that requires 
prompt remedial action for other subjects, users or other persons or a new finding to such a serious adverse 
event, sponsor must immediately but no later than two calendar days after awareness by sponsor report the 
event to national regulatory authorities. 
It is the responsibility of sponsor to inform all investigators in writing within ten working days if device deficien-
cies, adverse events, adverse device effects, near-incidents, serious adverse events, serious adverse device 
effects or unanticipated serious adverse device effects lead to corrective actions (e.g. change of IFU). 

 
 
 
Page 57 of 67 
 
CONFIDENTIAL 
 
 
15. Suspension or premature termination of the clinical investigation 
Sponsor may suspend or prematurely terminate an investigation site or the entire clinical investigation for 
documented significant reasons.  
If a suspicion of an unacceptable risk to subjects develops during the clinical investigation, Sponsor will sus-
pend the investigation while the risk is assessed. Sponsor will terminate the investigation if an unacceptable 
risk is confirmed. Sponsor will ensure that the premature termination will be justified in writing and will promptly 
inform the regulatory authorities and relevant EC(s). If monitoring or auditing of the clinical investigation iden-
tifies serious or repeated deviations at one of the participating investigation sites, sponsor will suspend or 
terminate the particular investigation site. The sponsor or investigator will inform the regulatory authority as 
appropriate and notify the EC about the termination of the site.  
If suspension or termination of the clinical investigation occurs, the investigator(s) will promptly inform the 
enrolled subjects. Sponsor will provide resources to fulfil the obligations from the CIP for follow-up of the sub-
jects as necessary. 
 

 
 
 
Page 58 of 67 
 
CONFIDENTIAL 
 
 
16. Clinical investigation report 
At completion of the investigation sponsor is responsible for writing the clinical investigation report. The report 
is retained on file. The report contains a critical evaluation of all data, which have been collected during the 
investigation. The report describes the methodology and design and a data analysis, including statistical prep-
aration and conclusion. 
Sponsor and national coordinating investigators must sign the final version of the clinical investigation report 
or an affidavit, indicating their agreement with the contents. If no coordinating investigators are appointed, then 
the signatures of the principal investigators should be obtained. 
The clinical investigation report will be submitted to relevant Ethics Committees and regulatory authorities 
within one year after last subject out. 
 
 
 

 
 
 
Page 59 of 67 
 
CONFIDENTIAL 
 
 
17. Publication policy 
17.1. General 
Coloplast, sponsor, is referring to the internal document ’Clinical Publication Policy’ that will be available for 
internal and external persons involved in the publication process. 
The investigation will be registered on a public accessible database, e.g. www.ClinicalTrial.gov, before re-
cruitment of the first subject. The results of the investigation, positive as well as inconclusive and negative 
will be published in the same public accessible database. The subjects’ identity will remain confidential. Pub-
lication of results in the database will be conducted per the law of personal data protection and will be initi-
ated as soon as scientifically acceptable, however, within one year after the last subject has completed the 
investigation. Data from the investigation is considered confidential until it is published per the conditions of 
this CIP and the ‘Clinical Publication Policy’. Sponsor may publish anonymous single subject case stories (or 
public, if the subject consents) at any time during and after the investigation. The identification of the partici-
pant must not be possible. Sponsor reserves the right to use the data (published and unpublished) for reim-
bursement or regulatory purposes. 
 
 
 

 
 
 
Page 60 of 67 
 
CONFIDENTIAL 
 
 
 
18. Bibliography 
 
[1] Coloplast-A/S, “Investigator's Brochure CP300 
)”.  
[2] M. H. S. M. P. R. A. Y. L. M. K. J. Janet Stoia Davis, “Factors impairing quality of life for people with an 
ostomy,” gastrointestinal Nursing, 2011.  
 
 
 
 

 
 
 
Page 61 of 67 
 
CONFIDENTIAL 
 
 
20. Appendix 
20.1. Appendix 1: LOCAL CHANGE LOG 
A Local Change Log should be created per country specific CIP (e.g. one Local Change Log for French CIP 
and one Local Change Log for Danish CIP).  
VERSION 
NUMBER 
ISSUED BY 
(INITIALS) 
COMMENTS (MAJOR CHANGES SINCE LAST REVISION) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
Page 62 of 67 
 
CONFIDENTIAL 
 
 
20.2. Appendix 2: Leakage scale questionnaire 
Emotional impact 
When you thought about your ostomy device and the risk of leakage, what emotions did you feel? 
In the last 7 days, due to leakage or worry about leakage… 
All of the time 
Often 
Sometimes 
Rarely or never 
I felt panic 
0 
1 
2 
3 
I felt stressed out 
0 
1 
2 
3 
I felt more afraid about leaks in the future 
0 
1 
2 
3 
I felt worry 
0 
1 
2 
3 
I felt frustrated 
0 
1 
2 
3 
I felt embarrassed 
0 
1 
2 
3 
I felt worried that I might leak 
0 
1 
2 
3 
I couldn't sleep 
0 
1 
2 
3 
I kept waking up at night to check my stoma 
0 
1 
2 
3 
I kept checking my ostomy bag to see if I have leaked 
0 
1 
2 
3 
 
Usual and Social activities 
When you thought about your ostomy device and the risk of leakage, how did it affect your activities? 
In the last 7 days due to leakage or worry about leakage… 
All of the time 
Often 
Sometimes 
Rarely or never 
Not applicable 
I decided to stay at home 
0 
1 
2 
3 
9 
I couldn't do light activities 
0 
1 
2 
3 
9 

 
 
 
Page 63 of 67 
 
CONFIDENTIAL 
 
 
I changed my plans 
0 
1 
2 
3 
9 
I was unable to go out and meet family and friends 
0 
1 
2 
3 
9 
I avoided close physical contact with family and friends 
0 
1 
2 
3 
9 
I did not want to see people 
0 
1 
2 
3 
9 
I avoided people 
0 
1 
2 
3 
9 
I tried to avoid meeting new people 
0 
1 
2 
3 
9 
 
Coping and in control 
When you thought about your ostomy device and the risk of leakage, how did it affect your ability to cope? 
In the last 7 days, due to leakage or worry about leakage… 
All of the time 
Often  
Sometimes 
Rarely or never 
I felt in control 
0 
1 
2 
3 
I was able to cope 
0 
1 
2 
3 
I felt calm 
0 
1 
2 
3 
I saw my friends as I usually do 
0 
1 
2 
3 
 
 
 

 
 
 
Page 64 of 67 
 
CONFIDENTIAL 
 
 
20.3. Appendix 3: Quality of life questionnaire 
This questionnaire asks you about the use of the stoma appliance from this test period and your experiences. You will be asked questions about the discreetness 
of the stoma appliance, comfort relating to wearing the stoma appliance, confidence you have with the stoma appliance, and how the device impacts your social 
life. 
Please think about your experience with using the stoma appliance during the past seven days and please select the box that is closest to your current 
situation. There are no right or wrong answers. We want to understand how beneficial you think the stoma appliance is and also what problems you may have 
experienced with it. 
For each of the statements, think about how the specific issue affects you. Please answer ALL questions as honestly as you can, and please remember to 
answer the questions in relation to the past seven days only. 
 
HRQoL  
Discreetness  
1. 
It was difficult to hide the stoma appliance under clothing 
2. 
I was self-conscious about the appearance of the stoma appliance 
3. 
The stoma appliance limited the choice of clothes that I could wear   
4. 
The stoma appliance was obvious to other people 
5. 
The color of the stoma appliance was discreet 
6. 
It was difficult to hide the stoma appliance because of ballooning 
 
Comfort 
7. 
The stoma appliance was comfortable to wear 
8. 
I was not concerned about skin irritation under the stoma appliance (for example, feelings of burning, itching, pinching or pain) 
9. 
It was uncomfortable to remove the stoma appliance from my body 
10. I often forgot that I was wearing the stoma appliance 
11. The stoma appliance was comfortable as it fitted well to my body 
12. The stoma appliance disrupted my sleep during the night 
 
Confidence 
13. I was confident that the stoma appliance would not leak 
14. I worried that the stoma appliance would become loose from my body 
15. I felt confident that I could spend the night away from home despite wearing the stoma appliance 
16. I was confident the stoma appliance would not cause any problems for me 
17. I felt confident to take part in physical activities (for example, sports) whilst wearing the stoma appliance 
18. I worried that the stoma appliance would make a rustling noise. 

 
 
 
Page 65 of 67 
 
CONFIDENTIAL 
 
 
 
Social life 
19. I worried that my family and friends felt awkward around me because of the stoma appliance 
20. I felt my social life had been restricted because of the stoma appliance 
21. I avoided close physical contact with family and friends because of the stoma appliance 
22. I worried about whether I could have a relationship because of my stoma appliance 
23. I worried about whether the stoma appliance would affect my sex life 

 
 
 
Page 66 of 67 
 
CONFIDENTIAL 
 
 
20.4. Appendix 4: Safety Interview guide 
Interview guide - Safety 
 
Background information: 
The background information is asked to understand if the subject has experienced any problems or challenges 
during the test periods. And if so, in what situations and circumstances. The challenges can be changes in 
stoma behaviour, stoma shape, size or colour, abdominal troubles or changes in the subject general condition. 
We will ask questions to understand when and why they have answered as they have to better understand 
how the test products differ from their own product. 
- 
Introduce yourself 
- 
Inform the subject about the purpose and background for the interview  
- 
Use the following questions to lead the interview: 
o 
How is your general health? 
o 
How has your stoma behaved since your last visit? 
o 
Has your stoma behaved differently since your last visit?  
o 
How has your abdomen behaved since your last visit? 
o 
Have you had any abdominal troubles? 
 
 
 

 
 
 
Page 67 of 67 
 
CONFIDENTIAL 
 
 
20.5. Appendix 5: Interview guide (V6) and Follow-up 
Interview guide – V6 and follow-up 
The following topics will be used as a guide during the interviews 
- 
Introduction 
- 
Experience throughout CP300 
- 
Product change 
- 
Their journey 
- 
Products and routine 
- 
Prototype review 
- 
Close