A Clinical Investigation Evaluating Three New 1-piece Ostomy Products
Phase: NA
Conditions: Ileostomy - Stoma
Sponsor: Coloplast A/S

 
 
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CONFIDENTIAL 
 
 
Clinical Investigation Plan 
 
CP275 
A clinical investigation evaluating three new 1-piece ostomy products. 
April 2017 –  May 2018. 
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No unpublished information contained herein may be 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. 

 
 
 
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> 
TABLE OF CONTENTS 
 
2. 
List of personnel involved in the Investigation .................................................... 12 
2.1. Sponsor representatives ............................................................................................... 12 
2.2. Investigators ................................................................................................................... 12 
2.3. Other ............................................................................................................................... 12 
3. 
Identification and description of the investigational device ............................... 13 
3.1. Manufacture .................................................................................................................... 13 
4. 
Justification for the conduct of the clinical investigation ................................... 17 
5. 
Investigational device and clinical investigation risks and benefits .................. 17 
5.1. Anticipated benefits ....................................................................................................... 17 
5.2. Anticipated risk, side effects and disadvantages ........................................................ 17 
5.3. Benefits versus risks ..................................................................................................... 18 
6. 
Objectives and hypotheses of the clinical investigation ..................................... 18 
6.1. Objective ......................................................................................................................... 18 
6.2. Claims and intended performance to be verified ......................................................... 18 
6.3. Risks and anticipated adverse device effects to be assessed ................................... 18 
7. 
Design of the clinical investigation ....................................................................... 19 
7.1. General ........................................................................................................................... 19 
7.2. Investigational device and comparator(s) .................................................................... 24 
7.3. Subjects .......................................................................................................................... 24 
7.4. Procedures ..................................................................................................................... 28 
7.5. Monitoring Plan .............................................................................................................. 33 
8. 
Statistical considerations ...................................................................................... 34 
8.1. Statistical design, method and analytical procedures ................................................ 34 
8.2. Sample size .................................................................................................................... 35 
8.3. Level of significance and power ................................................................................... 36 
8.4. Drop-out .......................................................................................................................... 36 
8.5. Pass/fail criteria.............................................................................................................. 36 
8.6. Interim analysis .............................................................................................................. 37 
8.7. Statistical reason for termination of investigation ...................................................... 37 
8.8. Deviation(s) from statistical plan .................................................................................. 37 
9. 
Data management ................................................................................................... 37 
9.1. Data review, database cleaning, and issuing and resolving data queries ................. 37 
9.2. Verification, validation and securing of electronic clinical data systems .................. 37 

 
 
 
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9.3. Data retention ................................................................................................................. 38 
10. 
Amendments to the CIP ......................................................................................... 38 
11. 
Clinical Investigation Plan deviations ................................................................... 38 
12. 
Device Accountability ............................................................................................. 39 
13. 
Statement of compliance ....................................................................................... 39 
13.1. 
Ethics committee and regulatory authorities ............................................................ 39 
13.2. 
Data protection ........................................................................................................... 39 
13.3. 
Indemnity ..................................................................................................................... 40 
13.4. 
Financial conditions ................................................................................................... 40 
14. 
Informed consent process ..................................................................................... 41 
15. 
Adverse events, serious adverse events and device deficiencies ..................... 41 
15.1. 
Adverse events ........................................................................................................... 41 
15.2. 
Device deficiency ........................................................................................................ 42 
15.3. 
Serious adverse events .............................................................................................. 42 
15.4. 
Medical care of subjects ............................................................................................. 43 
15.5. 
Reporting and timelines ............................................................................................. 43 
16. 
Suspension or premature termination of the clinical investigation ................... 44 
17. 
Clinical investigation report ................................................................................... 44 
18. 
Publication policy ................................................................................................... 45 
18.1. 
General ........................................................................................................................ 45 
19. 
Bibliography ............................................................................................................ 45 
 
 
 

 
 
 
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> 
TABLE OF TABLES 
 
Table 1 chart showing the connection between visits and assessments. ............................................. 33 
Table 2 Anticipated adverse device effects and their likely incidence rates ......................................... 44 
 
 

 
 
 
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> 
TABLE OF FIGURES 
 
Figure 1: Test Product 1 & 2 1p. open bag……………………………………………………………15 
Figure 2: Test Product 3 1-piece open ostomy bag……………………………………………………15 
Figure 3: Investigation with three products. There is a total of three combination possibilities. ........... 20 
Figure 4 Two examples of how to make corrections in the CRF ........................................................... 34 
 
 

 
 
 
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> 
SYNOPSIS OF THE CLINICAL INVESTIGATION  
  
Objective 
The aim of the study is to investigate and understand how the peristomal skin react if 1) the topfilm on existing 
ostomy products is changed to a softer topfilm or 2) the adhesive is changed but the topfilm is the same.  
Primary endpoint and secondary endpoint(s) 
The primary objective is to investigate the impact change of a new topfilm or adhesive (on an existing ostomy 
product) has on mechanical trauma on the peristomal skin.  
Secondary objectives are  
• 
To investigate the impact change to a new topfilm or adhesive (on an existing) has on the handling (ap-
plication and removal) of the product. 
• 
To evaluate which combination of adhesive and topfilm that has less negative impact on the peristomal 
skin 
• 
To evaluate which combination of adhesive and topfilm that is most easy to handle (application and re-
moval) 
 
Pass/fail criteria 
No formal success criteria are applied in this explorative investigation. The investigation will provide valuable 
insight into how the peristomal skin react if the topfilm on existing ostomy products is changed to a softer 
topfilm or the adhesive is changed but the topfilm is the same on an existing product. 
Design of the investigation  
The investigation is an explorative, open-labelled, randomised, controlled, comparative study investigating 
three ostomy test products based on the CE-marked SenSura Mio (1-piece Open Flat) and SenSura (1-piece 
Open Flat). The study is designed with a run-in period and two test periods. The run-in period (14 days) is for 
potential subjects not currently using a SenSura Mio (1-piece Open Flat) or SenSura (1-piece Open Flat) 
product. The first test period includes use of 7 (+/-1) products (own) and the second period includes use of 14 
test products (+/-1 product). As subjects needs to change minimum every second day, each subject will be 
enrolled for maximum 42 (+/-5) days. The subjects using SenSura Mio will be randomised into one of two 
possible treatment groups. Subjects using SenSura will not be randomised as only one treatment arm is avail-
able. (see figure 1). Each treatment arm consists of two test periods in which the subjects will test their own 
product followed by the test product. The subject will receive 1 box with 20 test products. During the investi-
gation, there will be 6 visits, where visit 0 will be the information visit.    
Population 
The investigational population consists of Danish colostomy/ileostomy-operated subjects that comply with the 
following inclusion criteria: 
1. Have given written informed consent and in DK: signed a letter of authority 
2. Be at least 18 years of age and have full legal capacity 
3. Have had their colostomy/ileostomy for at least three months 
4. Have a colostomy/ileostomy with a diameter between 10 and 55 mm 
5. Be able to handle the Clinical App. and product themselves 
6. Must be able to use custom cut product 
7. Minimum change of product every second day 
8. If current product is SenSura Mio - Be willing to use Maxi bag during investigation 
9. Subject using SenSura or SenSura Mio flat 1 pc. open for at least two weeks before inclusion in the 
study. 
10. Negative result of a pregnancy test for women of childbearing age (only DK) 

 
 
 
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And exclusion criteria: 
1. Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low 
doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for 
rheumatoid arthritis) 
2. Are currently receiving or have within the past month received topical steroid treatment in the peristomal 
skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed. 
3. Are pregnant or breastfeeding** 
4. Are participating in other interventional clinical investigations or have previously participated in this in-
vestigation 
• Exception: Participation in other Coloplast in-house clinical investigations are accepted under the cir-
cumstances that the subject has paused the activities in the investigation and are otherwise comply-
ing with the inclusion and exclusion criteria of this protocol (CP275) 
5. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the 
investigator) 
6. Have known hypersensitivity towards any of the products used in the investigation  
 
Test products 
The test products are non-CE-marked, non-sterile, class 1, Coloplast 1-piece open ostomy appliances with 
hide-away bag which is intended for use in collecting output from ileostomies. 
  
Investigation approval 
The investigation will be approved by the EC in Denmark and the Danish and Medicines Agency before inves-
tigation initiation. 
 

 
 
 
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> 
LIST OF ABBREBIATIONS 
  
ABBREVIATION 
WRITTEN OUT 
EXPLANATION 
ADE 
Adverse Device Effect 
See section 15.1 
AE 
Adverse Event 
See section 15.1 
ASADE 
Anticipated Serious Adverse Device Ef-
fect 
See section 14.3.3 
CIP 
Clinical Investigation Plan 
 
CRF 
Case Report Form 
Questionnaire to be used for data collection 
CTM 
Clinical Trial Manager 
 
DQF 
Data Query Forms 
A DQF is a query specifically used in clinical research. The DQF 
is the primary data query tool from the sponsor to clarify discrep-
ancies and ask the investigator for clarification. The DQF is part 
of the data validation process in a clinical investigation. 
EC 
Ethics Committee 
 
IB 
Investigator’s Brochure 
Compilation of the current clinical and non-clinical information on 
the investigational medical device(s,) relevant to the clinical in-
vestigation. 
IFU 
Instruction For Use 
 
ITT 
Intention to Treat 
 
PI 
Principal Investigator 
Qualified person responsible for conducting the clinical investiga-
tion at an investigation site. If the clinical investigation is con-
ducted by a team of individuals at an investigation site, the PI is 
the responsible leader of the team. Whether this is the responsi-
bility of an individual or an institution can depend on national reg-
ulations. 
PP 
Per Protocol 
 
SADE 
Serious Adverse Device Effect 
See section 15.3 
SAE 
Serious Adverse Event 
See section 15.3 
USADE 
Unanticipated Serious Adverse Device 
Effect 
See section 15.3 
 
 
 
 

 
 
 
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> 
SIGNATURE PAGE  
All Sponsor parties declare by their signature on the electronic signature page to follow the Clinical Investiga-
tion Plan CP275 in accordance with the Declaration of Helsinki, ISO 14155 and the Medical Device Directive.  
SPONSOR 
COLOPLAST A/S 
HOLTEDAM 1 
DK-3050 HUMLEBÆK 
DENMARK 
+45 4911 1111 
 
 
 
 

 
 
 
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3. Identification and description of the investigational device 
The test products (ostomy appliance) which are tested in the CP275 clinical study are developed for people 
with an ileostomy requiring a flat 1-piece solution. 
3.1. Manufacture 
Coloplast A/S, Holtedam 1, 3050 Humlebæk, Denmark, manufactures the investigational device. 
3.1.1. Identification, traceability and labelling of device 
The test products (ostomy appliance) will be packed in retail boxes with 20 devices in each box. Each retail 
box will be provided with a production lot number. The examples below for test products 1A and 1B show a 
label that will be attached to each box in order to secure traceability and identification of the test products. 
Each label will contain the description of the actual product. Labels for test products 2A, 2B, 3A and 3B will 
have a similar label attached. See Investigators brochure. [5]. 
 

 
 
 
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Baseline data 
a) Gender 
b) Age 
c) Weight 
d) Height 
e) Type of stoma (ileostomy/colostomy) 
f) 
Duration of colostomy/ileostomy (year when created) 
g) Cause of the stoma (Crohn's disease/Colitis ulcerosa/Cancer/Other) 
h) Size of the stoma (diameter on widest place and height) 
i) 
Body check profile questionnaire (box 4: non or superficial creases/ Deep folds)  
j) 
Current product (brand, product name, item number, size)  
k) Use of accessories 
l) 
How often is the ostomy appliance normally changed? (At least twice a day/Once a day/Every 2nd 
day/Every 3rd day or more rare 
m) Randomized testproduct  
n) Run-in period (yes/no) 
 
After each product change during each test period: 
Handling of base plate (application, removal) 
a) How did you find detaching the base plate you just removed? (very difficult/ difficult/ accepta-
ble/easy/very easy) 
b) How did you find attaching the base plate you just applied? (very difficult/ difficult/ accepta-
ble/easy/very easy) 
 
 
Body fit/freedom of movements 
a) How was the base plate’s ability to fit to the body contours in the area around the stoma? (very 
poor/poor/acceptable/good/very good) 
 
b) How was the base plate’s ability to bend and stretch with your skin when your body moves? (very 
poor/ poor/ acceptable/ good/very good) 
 
 
What was the main reason for changing 
1 I followed my usual changing pattern 
 the product? 
1 I thought it would be nice with a clean product 
 
1 In preparation of an activity (ie. going out, doing sports, travel-
ling) 
 
1 The entire baseplate had become detached 
  
1 The outer edge of the baseplate had become detached 
 
1 The center of the baseplate had become detached 
 
1 I was afraid the baseplate would become detached 

 
 
 
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1 The area around the stoma was itching 
 
1 The area around the stoma was painful 
1 There was leakage underneath and outside the baseplate 
1 There was leakage underneath the baseplate (but not outside 
the baseplate) 
 
1 The bag was full of air (ballooning) 
 
1 There was a vacuum in the bag (pancaking) 
 
1 Due to study visit 
 
 
 If ’Other reason for change’, please specify:  
 
 
After each test period: 
 
Did you use any accessories in this test period?  
 
 0 
No 
 
 1 
Yes 
 
 
If ‘Yes’ which accessories did you use? Please tick all that apply. 
 
 
 1 
Adhesive remover (spray/wipes) 
 
 1 
Paste 
 
 1 
Rings 
 
 1 
Ostomy tape 
 
 1 
Ostomy belt 
 
 1 
Hernia belt 
 
 1 
Stoma powder 
 
 1 
Barrier lotion/crème/spray/wipes 

 
 
 
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4. Have a colostomy/ileostomy with a diameter 
between 10 and 55 mm 
The CP Test product are only produced in a size that 
allows cutting the hole in the baseplate from 10 to 55 
mm. 
5.Be able to handle the Clinical App. and product 
themselves 
In order to answer the CRF questions the subjects has 
to be able to handle the products themselves 
6.Must be able to use custom cut product 
To ensure products fits optimal around stoma. The 
study personnel must make sure that the subject 
knows how to cut the product in order for the base 
plate to fit optimal around the stoma. 
 
7.Minimum change of product every second day 
To ensure that subjects who changes their product 
every second day will test at least 14 products in the 
test period. Most 1-piece open users however change 
their products daily, i.e. these subjects will test at least 
14 products in the test period. 
  
8. Be willing to use Maxi bag during investigation 
Only this bag size will be produced 
9. Subject using Sensura or Sensura Mio flat 1 pc. 
open for at least two weeks before inclusion in the 
study. 
To see changes from current product with a new top-
film or adhesive and to ensure skin is in steady state. 
10. Negative result of a pregnancy test for women 
of childbearing age (only DK) 
 
Women of childbearing age must take a pregnancy 
test 
provided by the investigator before entering the study. 
The test 
shall show a negative result in order document that the 
subject 
is not pregnant. 
 
 
7.3.2. Exclusion criteria for subject selection 
Subjects complying with the following criteria must be excluded from participation in the clinical investigation: 
Exclusion criteria 
The subjects are not allowed to participate in case they: 
Justification for inclusion criteria: 
1.Are currently receiving or have within the past 2 
months received radio-and/or chemotherapy (low 
doses chemotherapy is allowed for other indica-
tions than cancer, e.g. below 15 mg methotrexate 
for rheumatoid arthritis) 
The skin undergoes major changes because of radio- 
and/or chemotherapy, and therefore, the skin might be 
more fragile to product changes. 
2.Are currently receiving or have within the past 
month received topical steroid treatment in the 
Steroid product on peristomal skin may interfere with 
the skin condition. Use of steroid product can make the 
skin more fragile to baseplate change. 

 
 
 
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The paper CRF will be completed by the study nurse. Any corrections in the paper CRF must be clearly signed 
and dated by authorised site personnel. The corrected entry must be crossed out so that the original entry is 
still legible. 
CRF and clinical trial app and Informed Consent Forms; patient files may be source data for subject baseline 
characteristics, possible adverse events, serious adverse events, concomitant medication, concomitant dis-
ease and ostomy history. 
Only the investigator, delegated site personnel and the sponsor representatives will have access to all the 
source data. The subject will have access to his/her own source data.  
7.5.2. Other methods for data quality assurance 
The sponsor, sponsor’s representative and/or investigational sites may be inspected by competent authorities 
or their representatives and likewise may be audited according to Coloplast’s internal quality audit plan and 
procedures. 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 Danish Medicines Agency, Ethics Committee 
and authorities from other countries.  
 
8. Statistical considerations 
8.1. 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. In light of 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 8 places (N, NE, E, SE, S, SW, W and NW) of the outer edge of 
the baseplate. The comparison in TEWL between the test products worn in the first and second test period is 
the primary objective of the investigation. This comparison will be made for all 3 arms. All TEWL data from the 
outer circle are analysed in a joint model.   
A linear mixed model will be applied to the log transformed TEWL data. The model will include fixed interaction 
effects of arm (1,2,3) and product (in first and second period). Further the model will include:  
• 
a random effect of subject 

 
 
 
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test visits will decrease the power. The three repeated measurements taken on three different visits will how-
ever limit the impact the different visits haves on the power. Furthermore, measurements are performed at 8 
different positions in the outer circle this is likely to increase power.  
Based on data from CP254 study it is assumed that the standard deviation of log-transformed TEWL 
(log(TEWL)) is 0.62. Further it is assumed that the correlation between the three repeated measurements of 
log(TEWL) assessed at the same position is 0.62, whereas the correlation between repeated measurements 
corresponding to two different test products is 0.27. In the below table the needed sample size is seen for 
varying values of the true ratio in TEWL and for different values of the power to demonstrate that the ratio is 
significantly different from 1 (that the 95% confidence interval excludes 1).  
Table: Subjects needed for test of each test product within an arm on peristomal skin. 
 
Power 
True  
TEWL Ratio 
0.8 
0.85 
0.9 
1.6 
16 
17 
19 
1.7 
12 
14 
16 
1.8 
11 
12 
13 
1.9 
9 
11 
11 
2.0 
8 
9 
10 
 
Based on these numbers 12 subjects should test each test product in order to ensure a power of 80% if the 
true ratio between subject’s current product and the test product is 1.7. To take a potential drop-out into ac-
count it is recommended to include a total of 15 subjects in each arm, resulting in a total of 45 subjects. 
With 12 subjects in each arm there are 87% power to detect a true TEWL ratio of 2.2 between the test product 
ratios in 2 different arms (where TEWL measured on the subjects are not paired). 
8.3. Level of significance and power 
Statistical tests will be carried out as two sided tests on a 5% level of significance. For information regarding 
the power, see the above section 
8.4. Drop-out 
It is assumed that 20% of the subjects may drop out during the investigation. To ensuring 12 completers in 
each arm, 15 subjects will be allocated to each of the 3 arms, adding up to a total of 45 subjects 
8.5. Pass/fail criteria 
No formal success criteria are applied in this explorative investigation. The investigation will provide valuable 
insight into how the peristomal skin react if the topfilm on existing ostomy products is changed to a softer 
topfilm or the adhesive is changed but the topfilm is the same on an existing product. 

 
 
 
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8.6. Interim analysis  
The sample size calculation (see section 8.2) was performed in a simplified model without an assumed vari-
ance component for variation between visits and position of measurements as the variation was unknown at 
the time of sample size calculation. After including part of the planned subjects, it is possible to get an estimate 
of the variance components. Hence, an interim analysis will be performed to get an estimate of the variance 
components and a better estimate of the total variation after at least 8 finalized subjects in each arm. If the 
results of the interim analysis show less variation than assumed in the sample size calculation and/or a higher 
TEWL ratio than assumed, then it may be possible to show significant difference between the test products 
with a smaller sample size. If it is possible to evaluate how the peristomal skin react if 1) the topfilm on existing 
ostomy products is changed to a softer topfilm or 2) the adhesive is changed but the topfilm is the same, based 
on the interim results, the recruitment will be stopped to avoid unnecessary inconvenience for subjects.  
The interim analysis will be performed in a population that fulfill the ITT criteria by the trial statistician as this is 
an exploratory investigation and the results only will be used for internal decision making. 
The interim analysis will consist of: 
- 
Analysis of primary endpoint: TEWL 
- 
 
 
 
 
 Statistical reason for termination of investigation 
If the results of interim analysis are sufficient for evaluating the objective of the exploratory study the recruit-
ment of subjects will be stopped  
8.8. Deviation(s) from statistical plan 
Any deviations from the statistical plan will be documented in the clinical report  
 
9. Data management 
9.1. Data review, database cleaning, and issuing and resolving data queries 
Data management and statistical analyses is carried out by the Medical Affairs, Coloplast A/S.  
To ensure correct data entry, data from CRF is entered twice (double data entry). Data management is re-
sponsible 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 statistical analyses are performed.  
9.2. 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.  

 
 
 
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For collection of the patient diary data, Coloplast A/S uses a newly developed clinical trial application delivered 
by “Blue Fragment”. 
9.3. 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. 
 
10. Amendments to the CIP 
Any significant changes to the CIP must be:  
• Agreed between the sponsor and the investigator 
• Justified in a statement included in the amended section. The version number and date of amendment 
must be documented 
• Registered in the Change Log 
• Notified to or approved by the Ethical Committee of the Capital Region of Denmark before implementation 
• Notified to or approved by the Danish Medicine Agency before implementation 
 
Examples of significant changes include: changes to inclusion criteria, endpoints or assessment methods. 
 
11. Clinical Investigation Plan deviations 
The investigator is not allowed to deviate from the CIP unless under emergency circumstances and to pro-
tect the rights, safety and well-being of the subject(s). Deviations must be reported to the sponsor and devia-
tions affecting the scientific aspect of the investigation or the safety of the subject are reported to the Ethical 
Committee of the Capital Region of Denmark and Danish Medicine Agency by the sponsor, if required. 
 
Definition of deviation: 
Deviations are changes that affect the rights, safety and well-being of the subject(s), e.g. missed informed 
consent, an enrolled subject that does not fulfil the inclusion criteria or a serious adverse event that is not 
reported to the sponsor. 
Minor deviations could include administrative changes, change of monitor(s), changes to telephone numbers, 
and renewal of insurance.  
In the case of continued or repeated deviations affecting the subjects’ rights, safety and well-being, the sponsor 
will disqualify the investigator from further participation in the investigation. 

 
 
 
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12. 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 CIP. 
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 PI or an authorized designee keeps records documenting the receipt, use and return and disposal of the 
investigational devices, which includes: 
• Date of receipt 
• Identification of each investigational device (lot number) 
• The expiry date 
• The date of return of unused, expired or malfunctioning investigational devices 
• Subject identification 
 
13. 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 Di-
rective). 
• ISO 14155:2011 “Clinical Investigation of medical devices for human subjects – Good clinical practices”. 
• Any applicable regional or national regulations will be specified in the country specific CIP. 
• Executive Order on Medical Devices no. 1263 of 15 December 2008 (Bekendtgørelse om medicinsk ud-
styr nr. 1263 af 15. december 2008) 
•  EC Directive 95/46/EF regarding data protection, Jan. 2012 
•  Act of processing of Personal data Act. no. 429 of 31 May 2000 
13.1. 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. 
13.2. Data protection   
Information about subject identity is filed as a confidential document by the investigator(s) and subjects are 
referred to only as numbers on all other documents. The data is blinded correspondingly in the data analysis. 
Should the investigation require future review, relevant regulatory authorities and ethics committees will be 
allowed access to all relevant information for audit and inspection purposes. 

 
 
 
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14. Informed consent process 
Written informed consent is obtained from all subjects participating in the following detailed written and verbal 
briefing.  
The informed consent process takes place in a room reserved for the purpose of 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. If he decides 
to participate in the study, he signs the written informed consent form.  
The investigator, or study nurse, provides a non-technical version of the information to the subject in native 
language. Each subject will be fully informed about the aim of the investigation, procedures, potential risks or 
inconveniences and/or expected benefits. Subjects will have time to ask questions and have a minimum of 24 
hours before deciding on whether or not to participate in the investigation. If the subject wishes to consent 
immediately after receiving information, he may do so and in- and exclusion may be initiated. Subjects will be 
informed that their participation is voluntary and that they may leave the investigation at any time, without 
influencing any current or future treatment they may have outside this clinical investigation. 
Those who decide to participate will be asked to fill out an informed consent form, which the investigator or 
study nurse and subject will sign and date. He will also be asked to fill out the letter of authority, giving repre-
sentatives from Coloplast A/S, Investigator, Danish Medicine Agency and possible third countries access to 
relevant data registered in the investigation. The subjects will be given a copy of the signed informed consent 
form and letter of authority.  
If the subject in the Informed Consent Form has accepted that his personal physician may be informed about 
his participation in the study, a letter stating this will be sent by the investigator or study nurse to the personal 
physician with the purpose of adding this to the subjects’ patient record. If the subject has not accepted that 
his personal physician is informed, he may be included anyway. This is considered acceptable as investigator 
informs the subject to contact him should an adverse event occur. 
If new information becomes available during the investigation, the sponsor will inform the investigator, and 
the new information will be provided to the subjects by the investigator. If new information becomes available 
that can significantly affect a subject’s future health and medical care, the information will be provided to the 
subjects in written form. The clinical manager is responsible for producing the written information and provid-
ing it to investigators who will provide it to the subjects. If applicable, all affected subjects will be asked to 
confirm their continued informed consent in writing. 
 
15. Adverse events, serious adverse events and device deficiencies 
15.1. Adverse events  
15.1.1. 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. 
15.1.2. 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. 

 
 
 
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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 2 lists anticipated adverse device effects that may occur. 
Table 2 Anticipated adverse device effects and their likely incidence rates 
ANTICIPATED ADE 
INCIDENCE RATE 
Peristomal skin irritation  (incl. mechanical trauma) 
Allergic peristomal skin irritation (dermatitis) 
 
 
 
 
 
 
 
Temporary redness upon removal of the base plate is not considered an adverse device effect, however an 
abnormal development in intensity or duration should be considered as such.  
15.2. 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 secondary endpoints that are measured during this investigation will not be required to be reported 
as device deficiencies. 
15.3. Serious adverse events  
15.3.1. 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. 

 
 
 
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15.3.2. 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. 
15.3.3. 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. 
15.3.4. 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. 
15.4. 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. 
15.5. Reporting and timelines 
15.5.1. Investigators reporting responsibilities 
• 
PI at each site 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 within 2 work-
ing days.  
• 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 
within 2 working days. 
• New findings and/or updates in relation to already reported serious events should also be reported to 
sponsor within working 2 days. 
• 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. 
 
 
15.5.2. Sponsors reporting responsibilities 
It is the responsibility of sponsor to ensure that the following are reported to national regulatory authorities 
immediately, but no later than 7 calendar days following the date of awareness by sponsor.  
• All serious adverse events. 
• All serious device effects.  

 
 
 
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• 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 2 calendar days after awareness by sponsor report the 
event to national regulatory authorities. 
Sponsor must inform all investigators in writing within ten days after the sponsor is made aware, if an (S)AE 
or Device Deficiency led to corrective actions (e.g change of IFU) 
 
16. 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). 
 
17. 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 coordinating investigator must sign the final version of the clinical investigation report or an affi-
davit, indicating their agreement with the contents. If no coordinating investigator is appointed, then the signa-
tures of the principal investigator(s) should be obtained.    
The clinical investigation report must be submitted to EC and regulatory authorities (if relevant) 

 
 
 
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18. Publication policy 
18.1. General 
In connection with the publication policy Coloplast is referring to the internal document ’Clinical Publication 
Practice’ that will be available for internal and external persons involved in the publication process. 
The results of the investigation, positive as well as negative and inconclusive will be registered and published 
on clinicaltrials.gov webpage. The subjects’ identity will remain confidential. The results will not be submitted 
to a scientific journal. Publication of results on the webpage will be initiated as soon as scientifically accepta-
ble and according to the law of personal data protection (Lov om behandling af Personoplysninger), however 
within one year after the last subject has completed the investigation. Data from the investigation is consid-
ered confidential until it is published according to the conditions of this CIP and the ‘Clinical Publication Prac-
tice’. Sponsor may publish anonymous single subject case stories (or public, if the subject consents) at any 
time during and after the investigation. 
Sponsor reserves the right to use the data (published and unpublished) for reimbursement or regulatory pur-
poses. 
 
19. Bibliography 
[1] Porret T et al. DialogueStudy: An international real-life study of stoma care nursing using a new ostomy 
appliance. Gastrointestinal Nursing. 2011 Mar 9(2) (Supplement): 1-24. 
[2] Nybaek H, Knudsen DB, Laursen TN, Karlsmark T, and Jemec GB. Quality of life assessment among 
patients with peristomal skin disease. Eur J Gastroenterol Hepatol. 2010 Feb; 22(2): 139-43. 
[3] Product Risk Assessment CP275 Veeva no.: VV0128400 
[4] Biological Evaluation Report CP275 Veeva no.: VV0127825 
[5] Investigators Brochure CP275 Veeva no.: VV0127486