Trial Outcomes & Findings for Safety and Performance of New 1-piece Ostomy Product (NCT NCT01800916)
NCT ID: NCT01800916
Last Updated: 2017-04-14
Results Overview
The degree of leakage is measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change. The subjects had to tick off one of the following choices: 1. No leakage 2. Starting to leak 3. Leakage 4. Sudden Leakage
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
one week
Results posted on
2017-04-14
Participant Flow
Recruitment was performed primarily via Coloplast own subject database. In Norway recruitment also took place through medical clinics and hospitals.
65 participants were recruited. However, one participant was a screen failure and was not randomized and did not try any products.
Participant milestones
| Measure |
Test A/Test B/SenSura
The subjects first tested Coloplast test product A then Coloplast test product B and finally the comparator SenSura
|
Test A/Test C/SenSura
The subjects first tested Coloplast test product A then Coloplast test product C and finally the comparator SenSura
|
Test B/SenSura/Test A
The subjects first tested Coloplast test product B then SenSura and finally Coloplast test product A
|
Test B/SenSura/Test C
The subjects first tested Coloplast test product A then SenSura and finally Coloplast test product B
|
Test C/Test B/SenSura
The subjects first tested Coloplast test product C then Coloplast test product A and finally the comparator SenSura
|
Test C/SenSura/Test A
The subjects first tested Coloplast test product C then SenSura and finally Coloplast test product A
|
SenSura/Test A/Test B
The subjects first tested SenSura then Coloplast test product A and finally Coloplast test product B
|
SenSura/Test A/Test C
The subjects first tested SenSura then Coloplast test product A and finally Coloplast test product C
|
SenSura/Test C/Test B
The subjects first tested SenSura then Coloplast test product C and finally Coloplast test product B
|
|---|---|---|---|---|---|---|---|---|---|
|
Test Period 1 (1 Week)
STARTED
|
7
|
7
|
7
|
7
|
8
|
7
|
7
|
7
|
7
|
|
Test Period 1 (1 Week)
COMPLETED
|
7
|
7
|
7
|
6
|
7
|
7
|
7
|
7
|
7
|
|
Test Period 1 (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Test Period 2 (1 Week)
STARTED
|
7
|
7
|
7
|
6
|
7
|
7
|
7
|
7
|
7
|
|
Test Period 2 (1 Week)
COMPLETED
|
7
|
7
|
7
|
6
|
7
|
7
|
7
|
7
|
7
|
|
Test Period 2 (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Test Period 3 (1 Week)
STARTED
|
7
|
7
|
7
|
6
|
7
|
7
|
7
|
7
|
7
|
|
Test Period 3 (1 Week)
COMPLETED
|
7
|
7
|
7
|
6
|
7
|
7
|
7
|
7
|
7
|
|
Test Period 3 (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test A/Test B/SenSura
The subjects first tested Coloplast test product A then Coloplast test product B and finally the comparator SenSura
|
Test A/Test C/SenSura
The subjects first tested Coloplast test product A then Coloplast test product C and finally the comparator SenSura
|
Test B/SenSura/Test A
The subjects first tested Coloplast test product B then SenSura and finally Coloplast test product A
|
Test B/SenSura/Test C
The subjects first tested Coloplast test product A then SenSura and finally Coloplast test product B
|
Test C/Test B/SenSura
The subjects first tested Coloplast test product C then Coloplast test product A and finally the comparator SenSura
|
Test C/SenSura/Test A
The subjects first tested Coloplast test product C then SenSura and finally Coloplast test product A
|
SenSura/Test A/Test B
The subjects first tested SenSura then Coloplast test product A and finally Coloplast test product B
|
SenSura/Test A/Test C
The subjects first tested SenSura then Coloplast test product A and finally Coloplast test product C
|
SenSura/Test C/Test B
The subjects first tested SenSura then Coloplast test product C and finally Coloplast test product B
|
|---|---|---|---|---|---|---|---|---|---|
|
Test Period 1 (1 Week)
Convex product user
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Test Period 1 (1 Week)
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Performance of New 1-piece Ostomy Product
Baseline characteristics by cohort
| Measure |
Overall Study Population
n=63 Participants
|
|---|---|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION 10.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: one weekPopulation: The subjects were randomized to one of nine possible treatment groups. Each group consisted of three equal periods in which the subjects tested two test products and the comparator product (SenSura 1-piece). An equal distribution among the three arms and nine different treatment groups was aimed for. The ITT population was used for the analysis.
The degree of leakage is measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change. The subjects had to tick off one of the following choices: 1. No leakage 2. Starting to leak 3. Leakage 4. Sudden Leakage
Outcome measures
| Measure |
Test A
n=286 baseplates
|
Test B
n=280 baseplates
|
Test C
n=291 baseplates
|
SenSura
n=417 baseplates
|
|---|---|---|---|---|
|
Degree of Leakage
|
50 percentage of baseplates with no leakage
|
44 percentage of baseplates with no leakage
|
41 percentage of baseplates with no leakage
|
60 percentage of baseplates with no leakage
|
Adverse Events
Test A
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Test B
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Test C
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
SenSura
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test A
n=42 participants at risk
|
Test B
n=42 participants at risk
|
Test C
n=42 participants at risk
|
SenSura
n=62 participants at risk
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
dehydration
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
2.4%
1/42 • Number of events 1 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/62 • The adverse events were collected during the investigation - up to three weeks
|
|
Gastrointestinal disorders
obstipation due to parastomal hernia
|
2.4%
1/42 • Number of events 1 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/62 • The adverse events were collected during the investigation - up to three weeks
|
Other adverse events
| Measure |
Test A
n=42 participants at risk
|
Test B
n=42 participants at risk
|
Test C
n=42 participants at risk
|
SenSura
n=62 participants at risk
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
peristomal skin irritation
|
33.3%
14/42 • Number of events 19 • The adverse events were collected during the investigation - up to three weeks
|
23.8%
10/42 • Number of events 14 • The adverse events were collected during the investigation - up to three weeks
|
16.7%
7/42 • Number of events 8 • The adverse events were collected during the investigation - up to three weeks
|
12.9%
8/62 • Number of events 8 • The adverse events were collected during the investigation - up to three weeks
|
|
Gastrointestinal disorders
diarre
|
2.4%
1/42 • Number of events 1 • The adverse events were collected during the investigation - up to three weeks
|
2.4%
1/42 • Number of events 1 • The adverse events were collected during the investigation - up to three weeks
|
2.4%
1/42 • Number of events 1 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/62 • The adverse events were collected during the investigation - up to three weeks
|
|
General disorders
headache
|
4.8%
2/42 • Number of events 2 • The adverse events were collected during the investigation - up to three weeks
|
2.4%
1/42 • Number of events 1 • The adverse events were collected during the investigation - up to three weeks
|
2.4%
1/42 • Number of events 1 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/62 • The adverse events were collected during the investigation - up to three weeks
|
|
Skin and subcutaneous tissue disorders
skin irritation
|
2.4%
1/42 • Number of events 1 • The adverse events were collected during the investigation - up to three weeks
|
2.4%
1/42 • Number of events 1 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/62 • The adverse events were collected during the investigation - up to three weeks
|
|
Gastrointestinal disorders
stomach pain
|
2.4%
1/42 • Number of events 1 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
1.6%
1/62 • Number of events 1 • The adverse events were collected during the investigation - up to three weeks
|
|
Gastrointestinal disorders
bleeding from rectum
|
2.4%
1/42 • Number of events 1 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
1.6%
1/62 • Number of events 1 • The adverse events were collected during the investigation - up to three weeks
|
|
Ear and labyrinth disorders
otitis left ear
|
2.4%
1/42 • Number of events 1 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/62 • The adverse events were collected during the investigation - up to three weeks
|
|
Immune system disorders
gout
|
2.4%
1/42 • Number of events 1 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/62 • The adverse events were collected during the investigation - up to three weeks
|
|
Infections and infestations
influenza
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
2.4%
1/42 • Number of events 1 • The adverse events were collected during the investigation - up to three weeks
|
2.4%
1/42 • Number of events 1 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/62 • The adverse events were collected during the investigation - up to three weeks
|
|
Gastrointestinal disorders
active colitis ulcerosa in remaining bowl
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
2.4%
1/42 • Number of events 1 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/62 • The adverse events were collected during the investigation - up to three weeks
|
|
Skin and subcutaneous tissue disorders
small blister on peristomal skin
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
2.4%
1/42 • Number of events 1 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/62 • The adverse events were collected during the investigation - up to three weeks
|
|
Gastrointestinal disorders
gastroenterotitis
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
1.6%
1/62 • Number of events 1 • The adverse events were collected during the investigation - up to three weeks
|
|
Skin and subcutaneous tissue disorders
skin injury on forehead and nose
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
1.6%
1/62 • Number of events 1 • The adverse events were collected during the investigation - up to three weeks
|
|
Infections and infestations
pertussis
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
0.00%
0/42 • The adverse events were collected during the investigation - up to three weeks
|
1.6%
1/62 • Number of events 1 • The adverse events were collected during the investigation - up to three weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60