An interventional study of CP321 in Stoma Ileostomy, sponsored by Coloplast A/S. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-22.
Sponsored by Coloplast A/S · Not applicable, Interventional, and Supportive care
People with intestinal stomas (especially an ileostomy) can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively.
To overcome this, Coloplast has developed a new supporting ostomy product, which has an adhesive sensor layer that should be place underneath the baseplate normally used by the subject.
Single arm design. Open-labelled Study duration: 21 days + 3 days.
Test product is a Digital Leakage Notification System. It consist of a sensor layer (worn beneath the baseplate), a transmitter attached to the sensor layer, a charger for charging of transmitter and an app, to be installed on a smartphone, which notifies the user of the status of their baseplate such as everything looks okay or there is a possible leakage.
Subjects are asked to use test product for 21 days. n=15 were using a phone with Android operating system and n=10 a phone with iOS operating system.
Coloplast A/S is the lead sponsor of 146 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: 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
System Performance Accuracy of Pictures
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
Time frame: 21 days
Frequency of Leakage Onto Clothes Before and After Use of Test Product
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.
Time frame: At V1 (baseline) and V2 (follow-up, Day 21)
Experience of Leakage Onto Clothes Compared to Only Using Usual Product
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).
Time frame: V2 (follow-up, Day 21)
Reliability of Notifications
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)
Time frame: V2 (follow-up, Day 21)
Ability to Move With Test Product
Q: Compared to your usual product, how was your freedom to move with test product? Much better - better - Same - Worse - Much worse
Time frame: V2 (follow-up, Day 21)
Subjects Worry of Leakage Before and After Use of Test Product
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
Time frame: At V1 (baseline) and V2 (follow-up, Day 21)
Confidence to Avoid Full Leakage With Test Product Compared to Only Using Usual Product
Q: Compared to your usual product, did you feel confident that you could avoid leakage onto clothes? Yes -No
Time frame: V2 (follow-up, Day 21)
Confidence in Daily Life Compared to Only Using Usual Product
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
Time frame: V2 (follow-up, Day 21)
Feeling of Control With Test Product Compared to Only Using Usual Product
Q: Compared to your usual product, did test product give you a feeling of leakage control? Yes, higher leakage control No, lower leakage control
Time frame: V2 (follow-up, Day 21)
Control of Leakage Progression With Test Product Compared to Only Using Usual Product
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
Time frame: V2 (follow-up, Day 21)
Feeling of Security With Test Product Compared to Only Using Usual Product
Q: Compared to your usual product, did you feel more or less secure with test product?
Time frame: V2 (follow-up, Day 21)
Evaluation of Confidence to Increase Social Activities With Test Product Compared to Only Using Usual Product
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
Time frame: V2 (follow-up, Day 21)
Evaluation of Sleep With Test Product Compared to Only Using Usual Product
Q: Compared with your usual product, did the test product affect your sleep? Yes, to the better Yes, to the worse No, the same
Time frame: V2 (follow-up, Day 21)
Confidence at Night With Test Product Compared to Only Using Usual Product
Compared with your usual product, to which degree did the test product give you confidence at night? Much higher - Higher - Same - Lower - Much lower
Time frame: V2 (follow-up, Day 21)
Evaluation of Users' Preference
Q: Which product solution do you prefer? Own product - Own product with test product
Time frame: V2 (follow-up, Day 21)
Reason for 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
Time frame: V2 (follow-up, Day 21)
Evaluation of Users' Peace of Mind With Test Product
Q: To which degree did the test product give you peace of mind? Very high degree- High degree- Low degree- Very low degree
Time frame: V2 (follow-up, Day 21)
To Evaluate Users' Assessment of QoL With Test Product Compared to Usual Product
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
Time frame: V2 (follow-up, Day 21)
Adhesive Residue to Skin
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
Time frame: V2 (follow-up, Day 21)
Adhesive Residue to Transmitter
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
Time frame: V2 (follow-up, Day 21)
| Milestone | Test Arm, Intention to Treat |
|---|---|
| Started | 25 |
| Completed | 25 |
| Not completed | 0 |
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
| Pictures | Test Arm, Intention to Treat |
|---|---|
| True positive | 122 |
| True negative | 126 |
| False positive | 24 |
| False negative | 45 |
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.
| Leakage episodes onto clothes | Test Arm, Intention to Treat |
|---|---|
| V1 | 2.84 (1.69 to 4.76) |
| V2 | 0.51 (0.19 to 1.36) |
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).
| Participants | Test Arm, Intention to Treat |
|---|---|
| Very high degree | 0 |
| High degree | 0 |
| Some degree | 2 |
| Low degree | 3 |
| Very low degree / Not at all | 18 |
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)
| Participants | Test Arm, Intention to Treat |
|---|---|
| Very high degree | 5 |
| High degree | 7 |
| Some degree | 6 |
| Low degree | 3 |
| Very low degree / Not at all | 2 |
Q: Compared to your usual product, how was your freedom to move with test product? Much better - better - Same - Worse - Much worse
| Participants | Test Arm, Intention to Treat |
|---|---|
| Much worse | 0 |
| Worse | 1 |
| Same | 16 |
| Better | 4 |
| Much better | 2 |
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
| Participants | Test Arm, Intention to Treat |
|---|---|
| V1 — Very high degree | 1 |
| V1 — High degree | 11 |
| V1 — Some degree | 11 |
| V1 — Low degree | 2 |
| V1 — Very low degree / Not at all | 0 |
| V2 — Very high degree | 0 |
| V2 — High degree | 1 |
| V2 — Some degree | 6 |
| V2 — Low degree | 8 |
| V2 — Very low degree / Not at all | 8 |
Q: Compared to your usual product, did you feel confident that you could avoid leakage onto clothes? Yes -No
| Participants | Test Arm, Intention to Treat |
|---|---|
| Yes | 18 |
| No | 5 |
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
| Participants | Test Arm, Intention to Treat |
|---|---|
| Much lower degree | 1 |
| Lower degree | 2 |
| Same degree | 5 |
| Higher degree | 10 |
| Much higher degree | 5 |
Q: Compared to your usual product, did test product give you a feeling of leakage control? Yes, higher leakage control No, lower leakage control
| Participants | Test Arm, Intention to Treat |
|---|---|
| Yes, higher leakage control | 18 |
| No, lower leakage control | 5 |
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
| Participants | Test Arm, Intention to Treat |
|---|---|
| Yes, higher control of leakage progression | 16 |
| No, lower control of leakage progression | 7 |
Q: Compared to your usual product, did you feel more or less secure with test product?
| Participants | Test Arm, Intention to Treat |
|---|---|
| I felt less secure | 1 |
| I felt more secure | 22 |
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
| Participants | Test Arm, Intention to Treat |
|---|---|
| I felt less confident | 2 |
| I felt more confident | 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
| Participants | Test Arm, Intention to Treat |
|---|---|
| Yes, to the better | 8 |
| Yes, to the worse | 0 |
| No, the same | 15 |
Compared with your usual product, to which degree did the test product give you confidence at night? Much higher - Higher - Same - Lower - Much lower
| Participants | Test Arm, Intention to Treat |
|---|---|
| Much lower degree | 0 |
| Lower degree | 1 |
| Same degree | 11 |
| Higher degree | 7 |
| Much higher degree | 4 |
Q: Which product solution do you prefer? Own product - Own product with test product
| Participants | Test Arm, Intention to Treat |
|---|---|
| Own product | 10 |
| Own product with test product | 13 |
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
| Participants | Test Arm, Intention to Treat |
|---|---|
| Preference for test product : Body fit | 2 |
| Preference for test product : Ability to bend and stretch | 1 |
| Preference for test product : Feeling of security | 10 |
| Preference for test product : Feeling of confidence | 2 |
| Preference for test product : Less fear of leakage onto clothes | 9 |
| Preference for test product : Discreet to wear | 2 |
| Preference for test product : Discreetness in leakage control | 10 |
| Preference for test product : Better sleep | 5 |
| Preference for test product : Less embarrassment | 1 |
| Preference for test product : Other | 0 |
| Preference for own product : Body fit | 5 |
| Preference for own product : Ability to bend and stretch | 3 |
| Preference for own product : Feeling of security | 3 |
| Preference for own product : Feeling of confidence | 0 |
| Preference for own product : Less fear of leakage onto clothes | 1 |
| Preference for own product : Discreet to wear | 3 |
| Preference for own product : Discreetness in leakage control | 4 |
| Preference for own product : Better sleep | 0 |
| Preference for own product : Less embarrassment | 0 |
| Preference for own product : Other | 1 |
Q: To which degree did the test product give you peace of mind? Very high degree- High degree- Low degree- Very low degree
| Participants | Test Arm, Intention to Treat |
|---|---|
| Very high degree | 6 |
| High degree | 10 |
| Low degree | 5 |
| Very low degree | 2 |
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
| Participants | Test Arm, Intention to Treat |
|---|---|
| No | 3 |
| Yes | 20 |
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
| Participants | Test Arm, Intention to Treat |
|---|---|
| Very low degree/Not at all | 6 |
| Low degree | 7 |
| Some degree | 7 |
| High degree | 2 |
| Very high degree | 1 |
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
| Participants | Test Arm, Intention to Treat |
|---|---|
| Very low degree/Not at all | 9 |
| Low degree | 5 |
| Some degree | 9 |
| High degree | 0 |
| Very high degree | 0 |
Collected over 21 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test Product | 0/25 (0%) | 0/25 (0%) | 2/25 (8%) |
| Event | Test Product |
|---|---|
| Skin redness and irritationSkin and subcutaneous tissue disorders | 2/25 |
| Age, Continuous(years) | Test Arm, Intention to Treat |
|---|---|
| Mean | 56 (36 to 80) |
| Sex: Female, Male(Participants) | Test Arm, Intention to Treat |
|---|---|
| Female | 10 |
| Male | 15 |
| Race and Ethnicity Not Collected(Participants) | Test Arm, Intention to Treat |
|---|
| Region of Enrollment(Participants) | Test Arm, Intention to Treat |
|---|---|
| Denmark | 25 |
| Type of stoma(Participants) | Test Arm, Intention to Treat |
|---|---|
| Ileostomy | 15 |
| Colostomy | 10 |
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Coloplast A/S