Trial Outcomes & Findings for Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy (NCT NCT01800890)
NCT ID: NCT01800890
Last Updated: 2014-08-06
Results Overview
The degree of leakage is assessed using a 4 point leakage scale developed by Coloplast A/S. The 4-point leakage scale has four choices 1. No leakage 2. Starting to leakage 3. Leakage 4. Sudden leakage Leakage was assessed at every baseplate change
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
10 days
Results posted on
2014-08-06
Participant Flow
The subject were recruited through the Coloplast user data base.
Thirty-one subjects signed the informed consent, but 2 subjects were screen failures and did not test any products. These two subjects are not included in the participant flow below.
Participant milestones
| Measure |
Test A/ Test B/ SenSura
The subjects first tested Coloplast test product A then Cololpast test product B and finally the comparator SenSura
|
Test A/ Test C/ SenSura
The subjects first tested Coloplast test product A then Cololpast test product C and finally the comparator SenSura
|
Test B/ SenSura/ Test A
The subjects first tested Coloplast test product B then the comparator SenSura and finally Cololpast test product A
|
Test B/ SenSura/ Test C
The subjects first tested Coloplast test product B then the comparator SenSura and finally Cololpast test product C
|
Test C/ Test B/ SenSura
The subjects first tested Coloplast test product C then Cololpast test product B and finally the comparator SenSura
|
Test C/ SenSura/ Test A
The subjects first tested Coloplast test product C then the comparator SenSura and finally Cololpast test product A
|
SenSura/Test A/Test B
The subjects first tested the comparator product SenSura then Coloplast test product A and finally Cololpast test product B
|
SenSura/Test A/Test C
The subjects first tested the comparator product SenSura then Coloplast test product A and finally Cololpast test product C
|
SenSura/Test C/Test B
The subjects first tested the comparator product SenSura then Coloplast test product C and finally Cololpast test product B
|
|---|---|---|---|---|---|---|---|---|---|
|
Test Period 1
STARTED
|
3
|
3
|
3
|
3
|
4
|
4
|
3
|
3
|
3
|
|
Test Period 1
COMPLETED
|
3
|
3
|
3
|
2
|
4
|
4
|
3
|
3
|
3
|
|
Test Period 1
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Test Period 2
STARTED
|
3
|
3
|
3
|
2
|
4
|
4
|
3
|
3
|
3
|
|
Test Period 2
COMPLETED
|
3
|
3
|
3
|
2
|
4
|
4
|
3
|
3
|
3
|
|
Test Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Test Period 3
STARTED
|
3
|
3
|
3
|
2
|
4
|
4
|
3
|
3
|
3
|
|
Test Period 3
COMPLETED
|
3
|
3
|
3
|
2
|
4
|
4
|
3
|
3
|
3
|
|
Test Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy
Baseline characteristics by cohort
| Measure |
Overall Study Population
n=28 Participants
baseline data is given for subjects in the ITT population
|
|---|---|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 daysThe degree of leakage is assessed using a 4 point leakage scale developed by Coloplast A/S. The 4-point leakage scale has four choices 1. No leakage 2. Starting to leakage 3. Leakage 4. Sudden leakage Leakage was assessed at every baseplate change
Outcome measures
| Measure |
Coloplast Test Product A
n=91 baseplates
new test product
|
Coloplast Test Product B
n=83 baseplates
new test product
|
Coloplast Test Product C
n=92 baseplates
new test product
|
SenSura
n=117 baseplates
The comparator
|
|---|---|---|---|---|
|
Degree of Leakage
|
1.8 units on a scale
Standard Deviation 0.7
|
1.8 units on a scale
Standard Deviation 0.7
|
1.9 units on a scale
Standard Deviation 0.9
|
1.7 units on a scale
Standard Deviation 0.8
|
Adverse Events
Coloplast Test Product A
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Coloplast Test Product B
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Coloplast Test Product C
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
SenSura
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Coloplast Test Product A
n=19 participants at risk
Coloplast Test product A is a new test product
|
Coloplast Test Product B
n=19 participants at risk
Coloplast Test product B is a new test product
|
Coloplast Test Product C
n=19 participants at risk
Coloplast Test product C is a new test product
|
SenSura
n=28 participants at risk
The comparator was the CE-marked product SenSura Click
|
|---|---|---|---|---|
|
Renal and urinary disorders
stenosis of catherter in the right kidney
|
0.00%
0/19
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
0.00%
0/19
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
0.00%
0/19
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
3.6%
1/28 • Number of events 1
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
Other adverse events
| Measure |
Coloplast Test Product A
n=19 participants at risk
Coloplast Test product A is a new test product
|
Coloplast Test Product B
n=19 participants at risk
Coloplast Test product B is a new test product
|
Coloplast Test Product C
n=19 participants at risk
Coloplast Test product C is a new test product
|
SenSura
n=28 participants at risk
The comparator was the CE-marked product SenSura Click
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
peristomal skin irritation
|
26.3%
5/19 • Number of events 5
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
26.3%
5/19 • Number of events 5
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
21.1%
4/19 • Number of events 4
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
14.3%
4/28 • Number of events 5
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
|
Skin and subcutaneous tissue disorders
stinging skin by fistel
|
0.00%
0/19
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
0.00%
0/19
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
5.3%
1/19 • Number of events 1
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
0.00%
0/28
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
|
Renal and urinary disorders
cramps in the right kidney with sever pain
|
5.3%
1/19 • Number of events 1
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
0.00%
0/19
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
0.00%
0/19
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
0.00%
0/28
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
|
Infections and infestations
influenza
|
0.00%
0/19
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
5.3%
1/19 • Number of events 1
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
0.00%
0/19
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
0.00%
0/28
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
|
Infections and infestations
cold
|
0.00%
0/19
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
5.3%
1/19 • Number of events 1
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
0.00%
0/19
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
0.00%
0/28
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/19
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
5.3%
1/19 • Number of events 1
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
0.00%
0/19
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
0.00%
0/28
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
|
Renal and urinary disorders
bladder infection
|
0.00%
0/19
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
0.00%
0/19
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
0.00%
0/19
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
3.6%
1/28 • Number of events 1
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
|
Skin and subcutaneous tissue disorders
peristomal skin irritaion
|
0.00%
0/19
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
0.00%
0/19
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
0.00%
0/19
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
3.6%
1/28 • Number of events 1
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
|
Gastrointestinal disorders
diarre due to food intolerance
|
0.00%
0/19
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
0.00%
0/19
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
5.3%
1/19 • Number of events 1
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
0.00%
0/28
The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place