Trial Outcomes & Findings for Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura (NCT NCT01799239)
NCT ID: NCT01799239
Last Updated: 2016-09-30
Results Overview
leakage is measured using a 4-point leakage scale developed by Coloplast A/S. At every baseplate change the subjects had to look at the skin facing side of the baseplate and access which of the four scenarios described below provided an accurate description of the baseplate. The subjects tick of one of the four possible answers: 1. No leakage 2. Starting to leak (leakage under the baseplate) 3. Leakage (seepage of faeces resulting in leakage on clothes) 4. Sudden leakage (the baseplate pops off resulting in sudden leakage under the baseplate and outside the baseplate)
COMPLETED
NA
32 participants
After each baseplate change over a period, of 7 days
2016-09-30
Participant Flow
The subjects were recruited from hospital sites in Sweden and in Germany subjects were recruit from the Coloplast database and from hospital sites.
The investigation was designed as a cross-over study where subjects that did not complete the 1 period as planned were allowed to continue to the next test period.
Participant milestones
| Measure |
First Test Product; Then SenSura
The subjects tested two products: In the first period the subjects tested the newly developed ostomy bag called Test product. In the second period the subjects tested the comparator SenSura
|
First SenSura, Then Test Product
The subjects tested two products: In the first period the subjects tested the comparator SenSura. In the second period the subjects tested the newly developed ostomy bag called Test product
|
|---|---|---|
|
Period 1 (7 Days)
STARTED
|
15
|
16
|
|
Period 1 (7 Days)
COMPLETED
|
12
|
15
|
|
Period 1 (7 Days)
NOT COMPLETED
|
3
|
1
|
|
Period 2 (7 Days)
STARTED
|
13
|
15
|
|
Period 2 (7 Days)
COMPLETED
|
11
|
14
|
|
Period 2 (7 Days)
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
First Test Product; Then SenSura
The subjects tested two products: In the first period the subjects tested the newly developed ostomy bag called Test product. In the second period the subjects tested the comparator SenSura
|
First SenSura, Then Test Product
The subjects tested two products: In the first period the subjects tested the comparator SenSura. In the second period the subjects tested the newly developed ostomy bag called Test product
|
|---|---|---|
|
Period 1 (7 Days)
Lack of Efficacy
|
1
|
0
|
|
Period 1 (7 Days)
Withdrawal by Subject
|
2
|
0
|
|
Period 1 (7 Days)
Protocol Violation
|
0
|
1
|
|
Period 2 (7 Days)
Withdrawal by Subject
|
1
|
1
|
|
Period 2 (7 Days)
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura
Baseline characteristics by cohort
| Measure |
Overall Study
n=29 Participants
Describing baseline data for all subjects in the ITT population
|
|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 15.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After each baseplate change over a period, of 7 daysleakage is measured using a 4-point leakage scale developed by Coloplast A/S. At every baseplate change the subjects had to look at the skin facing side of the baseplate and access which of the four scenarios described below provided an accurate description of the baseplate. The subjects tick of one of the four possible answers: 1. No leakage 2. Starting to leak (leakage under the baseplate) 3. Leakage (seepage of faeces resulting in leakage on clothes) 4. Sudden leakage (the baseplate pops off resulting in sudden leakage under the baseplate and outside the baseplate)
Outcome measures
| Measure |
Test Product
n=184 Baseplates
The new test product is a 1-piece open ostomy product with the intended use being collecting output from an ileostomy.
|
SenSura
n=167 Baseplates
CE marked and launched SenSura used in this investigation is a 1-piece open appliance with the intended use being to collect output from an ileostomy.
|
|---|---|---|
|
Leakage (Percentage of All Baseplates With Leakage)
|
34 percentage baseplates with leakage
|
35 percentage baseplates with leakage
|
Adverse Events
Test Product
SenSura
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Product
n=32 participants at risk
The new test product is a 1-piece open ostomy product with the intended use being collecting output from an ileostomy.
|
SenSura
n=32 participants at risk
CE marked and launched SenSura used in this investigation is a 1-piece open appliance with the intended use being to collect output from an ileostomy.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
pain in the peristomal area
|
0.00%
0/32 • The adverse events were collected for 14 days
The subject for whom it was unknown which intervention was recieved did not have any adverse events in the course of the study
|
3.1%
1/32 • Number of events 1 • The adverse events were collected for 14 days
The subject for whom it was unknown which intervention was recieved did not have any adverse events in the course of the study
|
|
Skin and subcutaneous tissue disorders
Itching in the peristomal area
|
3.1%
1/32 • Number of events 1 • The adverse events were collected for 14 days
The subject for whom it was unknown which intervention was recieved did not have any adverse events in the course of the study
|
3.1%
1/32 • Number of events 1 • The adverse events were collected for 14 days
The subject for whom it was unknown which intervention was recieved did not have any adverse events in the course of the study
|
|
Skin and subcutaneous tissue disorders
red skin in the peristomal area
|
3.1%
1/32 • Number of events 1 • The adverse events were collected for 14 days
The subject for whom it was unknown which intervention was recieved did not have any adverse events in the course of the study
|
0.00%
0/32 • The adverse events were collected for 14 days
The subject for whom it was unknown which intervention was recieved did not have any adverse events in the course of the study
|
Additional Information
Camilla Felsvang Vibjerg, Senior Clinical manager
Coloplast A/S
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60