Trial Outcomes & Findings for Investigation of a Supporting Ostomy Product Intended for Leakage Detection (NCT NCT04894084)
NCT ID: NCT04894084
Last Updated: 2023-09-22
Results Overview
The primary endpoint is system performance accuracy: * True Negative: No leakage observed on picture and no leakage detected by system * True Positive: Leakage observed in picture and leakage detected by system * False Negative: Leakage observed in picture, but no leakage detected by system * False Positive: No leakage observed in picture, but leakage detected by system
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
21 days
Results posted on
2023-09-22
Participant Flow
Participant milestones
| Measure |
Test Arm, Intention to Treat
All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured.
Single arm, open-label investigation with subjects assigned to use test product for 21±3 days.
Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Test Arm, Intention to Treat
n=25 Participants
All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured.
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|---|---|
|
Age, Continuous
|
56 years
n=25 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=25 Participants
|
|
Region of Enrollment
Denmark
|
25 Participants
n=25 Participants
|
|
Type of stoma
Ileostomy
|
15 Participants
n=25 Participants
|
|
Type of stoma
Colostomy
|
10 Participants
n=25 Participants
|
PRIMARY outcome
Timeframe: 21 daysThe primary endpoint is system performance accuracy: * True Negative: No leakage observed on picture and no leakage detected by system * True Positive: Leakage observed in picture and leakage detected by system * False Negative: Leakage observed in picture, but no leakage detected by system * False Positive: No leakage observed in picture, but leakage detected by system
Outcome measures
| Measure |
Test Arm, Intention to Treat
n=317 Pictures
All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured.
Single arm, open-label investigation with subjects assigned to use test product for 21±3 days.
Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
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|---|---|
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System Performance Accuracy of Pictures
True positive
|
122 Pictures
|
|
System Performance Accuracy of Pictures
True negative
|
126 Pictures
|
|
System Performance Accuracy of Pictures
False positive
|
24 Pictures
|
|
System Performance Accuracy of Pictures
False negative
|
45 Pictures
|
SECONDARY outcome
Timeframe: At V1 (baseline) and V2 (follow-up, Day 21)Subjects are asked to recall numbers of leakage events outside baseplate (and/or onto clothes) the past 3 weeks (at baseline and follow-up). Subjects shall give a specific frequency.
Outcome measures
| Measure |
Test Arm, Intention to Treat
n=25 Participants
All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured.
Single arm, open-label investigation with subjects assigned to use test product for 21±3 days.
Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
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|---|---|
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Frequency of Leakage Onto Clothes Before and After Use of Test Product
V1
|
2.84 Leakage episodes onto clothes
Interval 1.69 to 4.76
|
|
Frequency of Leakage Onto Clothes Before and After Use of Test Product
V2
|
0.51 Leakage episodes onto clothes
Interval 0.19 to 1.36
|
SECONDARY outcome
Timeframe: V2 (follow-up, Day 21)Subject own interpretation, Q: to which degree have you experienced leakage onto your clothes with test product?" (5-point scale: very low degree/not at all, low degree, some degree, high degree, very high degree).
Outcome measures
| Measure |
Test Arm, Intention to Treat
n=23 Participants
All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured.
Single arm, open-label investigation with subjects assigned to use test product for 21±3 days.
Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
|
|---|---|
|
Experience of Leakage Onto Clothes Compared to Only Using Usual Product
Very high degree
|
0 Participants
|
|
Experience of Leakage Onto Clothes Compared to Only Using Usual Product
High degree
|
0 Participants
|
|
Experience of Leakage Onto Clothes Compared to Only Using Usual Product
Some degree
|
2 Participants
|
|
Experience of Leakage Onto Clothes Compared to Only Using Usual Product
Low degree
|
3 Participants
|
|
Experience of Leakage Onto Clothes Compared to Only Using Usual Product
Very low degree / Not at all
|
18 Participants
|
SECONDARY outcome
Timeframe: V2 (follow-up, Day 21)Subjects are asked to rate, Q: To which degree did you find notifications from the app reliable and trustworthy (5-point scale; very low degree, low degree, some degree, high degree, very high degree)
Outcome measures
| Measure |
Test Arm, Intention to Treat
n=23 Participants
All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured.
Single arm, open-label investigation with subjects assigned to use test product for 21±3 days.
Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
|
|---|---|
|
Reliability of Notifications
Very high degree
|
5 Participants
|
|
Reliability of Notifications
High degree
|
7 Participants
|
|
Reliability of Notifications
Some degree
|
6 Participants
|
|
Reliability of Notifications
Low degree
|
3 Participants
|
|
Reliability of Notifications
Very low degree / Not at all
|
2 Participants
|
SECONDARY outcome
Timeframe: V2 (follow-up, Day 21)Q: Compared to your usual product, how was your freedom to move with test product? Much better - better - Same - Worse - Much worse
Outcome measures
| Measure |
Test Arm, Intention to Treat
n=23 Participants
All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured.
Single arm, open-label investigation with subjects assigned to use test product for 21±3 days.
Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
|
|---|---|
|
Ability to Move With Test Product
Much worse
|
0 Participants
|
|
Ability to Move With Test Product
Worse
|
1 Participants
|
|
Ability to Move With Test Product
Same
|
16 Participants
|
|
Ability to Move With Test Product
Better
|
4 Participants
|
|
Ability to Move With Test Product
Much better
|
2 Participants
|
SECONDARY outcome
Timeframe: At V1 (baseline) and V2 (follow-up, Day 21)Population: Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
Q: Think back on the last 3 weeks - to which degree have you worried about leakage? Very high degree - High degree - Some degree - Low degree - Very low degree/Not at all
Outcome measures
| Measure |
Test Arm, Intention to Treat
n=25 Participants
All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured.
Single arm, open-label investigation with subjects assigned to use test product for 21±3 days.
Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
|
|---|---|
|
Subjects Worry of Leakage Before and After Use of Test Product
V1 · Very high degree
|
1 Participants
|
|
Subjects Worry of Leakage Before and After Use of Test Product
V1 · High degree
|
11 Participants
|
|
Subjects Worry of Leakage Before and After Use of Test Product
V1 · Some degree
|
11 Participants
|
|
Subjects Worry of Leakage Before and After Use of Test Product
V1 · Low degree
|
2 Participants
|
|
Subjects Worry of Leakage Before and After Use of Test Product
V1 · Very low degree / Not at all
|
0 Participants
|
|
Subjects Worry of Leakage Before and After Use of Test Product
V2 · Very high degree
|
0 Participants
|
|
Subjects Worry of Leakage Before and After Use of Test Product
V2 · High degree
|
1 Participants
|
|
Subjects Worry of Leakage Before and After Use of Test Product
V2 · Some degree
|
6 Participants
|
|
Subjects Worry of Leakage Before and After Use of Test Product
V2 · Low degree
|
8 Participants
|
|
Subjects Worry of Leakage Before and After Use of Test Product
V2 · Very low degree / Not at all
|
8 Participants
|
SECONDARY outcome
Timeframe: V2 (follow-up, Day 21)Q: Compared to your usual product, did you feel confident that you could avoid leakage onto clothes? Yes -No
Outcome measures
| Measure |
Test Arm, Intention to Treat
n=23 Participants
All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured.
Single arm, open-label investigation with subjects assigned to use test product for 21±3 days.
Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
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|---|---|
|
Confidence to Avoid Full Leakage With Test Product Compared to Only Using Usual Product
Yes
|
18 Participants
|
|
Confidence to Avoid Full Leakage With Test Product Compared to Only Using Usual Product
No
|
5 Participants
|
SECONDARY outcome
Timeframe: V2 (follow-up, Day 21)Q: Compared to your usual product, to which degree did the test product give you confidence in daily life? Much higher degree- Higher degree- Same degree - Lower degree- Much lower degree
Outcome measures
| Measure |
Test Arm, Intention to Treat
n=23 Participants
All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured.
Single arm, open-label investigation with subjects assigned to use test product for 21±3 days.
Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
|
|---|---|
|
Confidence in Daily Life Compared to Only Using Usual Product
Much lower degree
|
1 Participants
|
|
Confidence in Daily Life Compared to Only Using Usual Product
Lower degree
|
2 Participants
|
|
Confidence in Daily Life Compared to Only Using Usual Product
Same degree
|
5 Participants
|
|
Confidence in Daily Life Compared to Only Using Usual Product
Higher degree
|
10 Participants
|
|
Confidence in Daily Life Compared to Only Using Usual Product
Much higher degree
|
5 Participants
|
SECONDARY outcome
Timeframe: V2 (follow-up, Day 21)Q: Compared to your usual product, did test product give you a feeling of leakage control? Yes, higher leakage control No, lower leakage control
Outcome measures
| Measure |
Test Arm, Intention to Treat
n=23 Participants
All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured.
Single arm, open-label investigation with subjects assigned to use test product for 21±3 days.
Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
|
|---|---|
|
Feeling of Control With Test Product Compared to Only Using Usual Product
Yes, higher leakage control
|
18 Participants
|
|
Feeling of Control With Test Product Compared to Only Using Usual Product
No, lower leakage control
|
5 Participants
|
SECONDARY outcome
Timeframe: V2 (follow-up, Day 21)Q: Compared to your usual product, did the test product give you a feeling of control of leakage progression? Yes, higher control of leakage progression No, lower control of leakage progression
Outcome measures
| Measure |
Test Arm, Intention to Treat
n=23 Participants
All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured.
Single arm, open-label investigation with subjects assigned to use test product for 21±3 days.
Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
|
|---|---|
|
Control of Leakage Progression With Test Product Compared to Only Using Usual Product
Yes, higher control of leakage progression
|
16 Participants
|
|
Control of Leakage Progression With Test Product Compared to Only Using Usual Product
No, lower control of leakage progression
|
7 Participants
|
SECONDARY outcome
Timeframe: V2 (follow-up, Day 21)Q: Compared to your usual product, did you feel more or less secure with test product?
Outcome measures
| Measure |
Test Arm, Intention to Treat
n=23 Participants
All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured.
Single arm, open-label investigation with subjects assigned to use test product for 21±3 days.
Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
|
|---|---|
|
Feeling of Security With Test Product Compared to Only Using Usual Product
I felt less secure
|
1 Participants
|
|
Feeling of Security With Test Product Compared to Only Using Usual Product
I felt more secure
|
22 Participants
|
SECONDARY outcome
Timeframe: V2 (follow-up, Day 21)Q: Compared with your usual product, did the test product affect your confidence to engage in social activities such as seeing friends, and do physical activities? I felt more confident - I felt less confident
Outcome measures
| Measure |
Test Arm, Intention to Treat
n=23 Participants
All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured.
Single arm, open-label investigation with subjects assigned to use test product for 21±3 days.
Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
|
|---|---|
|
Evaluation of Confidence to Increase Social Activities With Test Product Compared to Only Using Usual Product
I felt less confident
|
2 Participants
|
|
Evaluation of Confidence to Increase Social Activities With Test Product Compared to Only Using Usual Product
I felt more confident
|
21 Participants
|
SECONDARY outcome
Timeframe: V2 (follow-up, Day 21)Q: Compared with your usual product, did the test product affect your sleep? Yes, to the better Yes, to the worse No, the same
Outcome measures
| Measure |
Test Arm, Intention to Treat
n=23 Participants
All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured.
Single arm, open-label investigation with subjects assigned to use test product for 21±3 days.
Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
|
|---|---|
|
Evaluation of Sleep With Test Product Compared to Only Using Usual Product
No, the same
|
15 Participants
|
|
Evaluation of Sleep With Test Product Compared to Only Using Usual Product
Yes, to the better
|
8 Participants
|
|
Evaluation of Sleep With Test Product Compared to Only Using Usual Product
Yes, to the worse
|
0 Participants
|
SECONDARY outcome
Timeframe: V2 (follow-up, Day 21)Compared with your usual product, to which degree did the test product give you confidence at night? Much higher - Higher - Same - Lower - Much lower
Outcome measures
| Measure |
Test Arm, Intention to Treat
n=23 Participants
All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured.
Single arm, open-label investigation with subjects assigned to use test product for 21±3 days.
Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
|
|---|---|
|
Confidence at Night With Test Product Compared to Only Using Usual Product
Much lower degree
|
0 Participants
|
|
Confidence at Night With Test Product Compared to Only Using Usual Product
Lower degree
|
1 Participants
|
|
Confidence at Night With Test Product Compared to Only Using Usual Product
Same degree
|
11 Participants
|
|
Confidence at Night With Test Product Compared to Only Using Usual Product
Higher degree
|
7 Participants
|
|
Confidence at Night With Test Product Compared to Only Using Usual Product
Much higher degree
|
4 Participants
|
SECONDARY outcome
Timeframe: V2 (follow-up, Day 21)Q: Which product solution do you prefer? Own product - Own product with test product
Outcome measures
| Measure |
Test Arm, Intention to Treat
n=23 Participants
All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured.
Single arm, open-label investigation with subjects assigned to use test product for 21±3 days.
Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
|
|---|---|
|
Evaluation of Users' Preference
Own product
|
10 Participants
|
|
Evaluation of Users' Preference
Own product with test product
|
13 Participants
|
SECONDARY outcome
Timeframe: V2 (follow-up, Day 21)Population: The 13 subjects with a preference for test product were asked for the reason(s) for this preference and the the 10 subjects with a preference for own product were asked for the reason(s) for this preference.
Q: What is your reason for preference? (Please tick all that apply) * Body fit * Ability to bend and stretch * Feeling of security * Feeling of confidence * Less fear of leakage onto clothes * Discreet to wear * Discreetness in leakage control * Better sleep * Less embarrassment * Other
Outcome measures
| Measure |
Test Arm, Intention to Treat
n=23 Participants
All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured.
Single arm, open-label investigation with subjects assigned to use test product for 21±3 days.
Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
|
|---|---|
|
Reason for Preference
Preference for test product : Body fit
|
2 Participants
|
|
Reason for Preference
Preference for test product : Ability to bend and stretch
|
1 Participants
|
|
Reason for Preference
Preference for test product : Feeling of security
|
10 Participants
|
|
Reason for Preference
Preference for test product : Feeling of confidence
|
2 Participants
|
|
Reason for Preference
Preference for test product : Less fear of leakage onto clothes
|
9 Participants
|
|
Reason for Preference
Preference for test product : Discreet to wear
|
2 Participants
|
|
Reason for Preference
Preference for test product : Discreetness in leakage control
|
10 Participants
|
|
Reason for Preference
Preference for test product : Better sleep
|
5 Participants
|
|
Reason for Preference
Preference for test product : Less embarrassment
|
1 Participants
|
|
Reason for Preference
Preference for test product : Other
|
0 Participants
|
|
Reason for Preference
Preference for own product : Body fit
|
5 Participants
|
|
Reason for Preference
Preference for own product : Ability to bend and stretch
|
3 Participants
|
|
Reason for Preference
Preference for own product : Feeling of security
|
3 Participants
|
|
Reason for Preference
Preference for own product : Feeling of confidence
|
0 Participants
|
|
Reason for Preference
Preference for own product : Less fear of leakage onto clothes
|
1 Participants
|
|
Reason for Preference
Preference for own product : Discreet to wear
|
3 Participants
|
|
Reason for Preference
Preference for own product : Discreetness in leakage control
|
4 Participants
|
|
Reason for Preference
Preference for own product : Better sleep
|
0 Participants
|
|
Reason for Preference
Preference for own product : Less embarrassment
|
0 Participants
|
|
Reason for Preference
Preference for own product : Other
|
1 Participants
|
SECONDARY outcome
Timeframe: V2 (follow-up, Day 21)Q: To which degree did the test product give you peace of mind? Very high degree- High degree- Low degree- Very low degree
Outcome measures
| Measure |
Test Arm, Intention to Treat
n=23 Participants
All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured.
Single arm, open-label investigation with subjects assigned to use test product for 21±3 days.
Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
|
|---|---|
|
Evaluation of Users' Peace of Mind With Test Product
Very high degree
|
6 Participants
|
|
Evaluation of Users' Peace of Mind With Test Product
High degree
|
10 Participants
|
|
Evaluation of Users' Peace of Mind With Test Product
Low degree
|
5 Participants
|
|
Evaluation of Users' Peace of Mind With Test Product
Very low degree
|
2 Participants
|
SECONDARY outcome
Timeframe: V2 (follow-up, Day 21)Overall, do you think the test product can improve your feeling of control and confidence to avoid leakage onto clothes and therefore improve your quality of life? Yes - No
Outcome measures
| Measure |
Test Arm, Intention to Treat
n=23 Participants
All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured.
Single arm, open-label investigation with subjects assigned to use test product for 21±3 days.
Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
|
|---|---|
|
To Evaluate Users' Assessment of QoL With Test Product Compared to Usual Product
No
|
3 Participants
|
|
To Evaluate Users' Assessment of QoL With Test Product Compared to Usual Product
Yes
|
20 Participants
|
SECONDARY outcome
Timeframe: V2 (follow-up, Day 21)To which degree did you experience adhesive residue to the skin in the area around the transmitter? Very low degree/Not at all - Low degree - Some degree - High degree -Very high degree
Outcome measures
| Measure |
Test Arm, Intention to Treat
n=23 Participants
All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured.
Single arm, open-label investigation with subjects assigned to use test product for 21±3 days.
Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
|
|---|---|
|
Adhesive Residue to Skin
Very low degree/Not at all
|
6 Participants
|
|
Adhesive Residue to Skin
Low degree
|
7 Participants
|
|
Adhesive Residue to Skin
Some degree
|
7 Participants
|
|
Adhesive Residue to Skin
High degree
|
2 Participants
|
|
Adhesive Residue to Skin
Very high degree
|
1 Participants
|
SECONDARY outcome
Timeframe: V2 (follow-up, Day 21)To which degree did you experience adhesive residue on the backside of the transmitter? Very low degree/Not at all - Low degree - Some degree - High degree -Very high degree
Outcome measures
| Measure |
Test Arm, Intention to Treat
n=23 Participants
All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured.
Single arm, open-label investigation with subjects assigned to use test product for 21±3 days.
Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23.
|
|---|---|
|
Adhesive Residue to Transmitter
Very low degree/Not at all
|
9 Participants
|
|
Adhesive Residue to Transmitter
Low degree
|
5 Participants
|
|
Adhesive Residue to Transmitter
Some degree
|
9 Participants
|
|
Adhesive Residue to Transmitter
High degree
|
0 Participants
|
|
Adhesive Residue to Transmitter
Very high degree
|
0 Participants
|
Adverse Events
Test Product
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Product
n=25 participants at risk
Subjects are requested to use the test device (supporting product) beneath their ostomy baseplate. Subjects may change their appliance as they wish, either they may change due to a notification from the app and/or follow their change routine.
CP321: The primary objective is to evaluate the system performance of the test product. This is done by asking subjects to answer questions throughout the study
|
|---|---|
|
Skin and subcutaneous tissue disorders
Skin redness and irritation
|
8.0%
2/25 • Number of events 2 • 21 days
During Visit 2, potential (S)AE's was captured by the Principal Investigator, or delegate.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60