Stoma IleostomyNCT04894084
Investigation of a Supporting Ostomy Product Intended for Leakage Detection
A study testing CP321 in people with Stoma Ileostomy, run by Coloplast A/S at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma Ileostomy
- What is being tested?
- CP321
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 29 Apr 2021to 14 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Have had a stoma for more than three months
- Have intact skin on the area used in the evaluation meaning no broken skin and only minor discoloration of the skin (assessed by investigator)
- Be able to use one of the five sensor layer sizes (i.e. Ø40, Ø50, Ø60, Ø70, Ø80 mm)
- Ileo- or colostomists with liquid output (Bristol scale type 6-7).
Show all 10Show fewer
- Currently using a Coloplast product (1pc/2pc Flat/Convex/Concave) from e.g Assura/SenSura/SenSura Mio
- Have self-reported problems with leakage* (three times within 14 days)
- Have worry of leakage 'to some, high or very high degree'
- Is familiar with the use of a smartphone *Leakage: Leakage is defined as output from the stoma on the backside of the baseplate (underneath the baseplate)
Who cannot join
- Currently receiving or have within the past 2 month received radio- and/or chemotherapy
- Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
- Are pregnant or breastfeeding
- Participating in other interventional clinical investigations or have previously participated in this investigation. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this protocol.
- Known sensitivity towards test product
- Known sensitivity towards acrylate
- Is using/have a pacemaker
- Is using ostomy paste or ostomy powder
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Stoma Ileostomy
- Being tested
- CP321
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP321Device
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
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | 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. Receives: Device: CP321 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 21 days
Secondary outcomes (19)
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.
Measured: 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).
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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?
Measured: 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
Measured: 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
Measured: 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
Measured: V2 (follow-up, Day 21)
Evaluation of Users' Preference
Q: Which product solution do you prefer? Own product - Own product with test product
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: V2 (follow-up, Day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start29 Apr 2021
- Primary completion14 Jul 2021
- Study completion14 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stoma IleostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, open label study. Subjects are allocated to use test product for 3 weeks. Subjects will complete questionnaires at baseline (V1) and again after 3 weeks use of test product (V2). Comparative tests included: Baseline vs. follow-up measures.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Søren Meisner, MD, Principal investigator, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894084
- Sponsor's protocol ID
- CP321
- Status last verified
- Aug 2023
- First submitted
- 16 May 2021
- Last updated
- 22 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brady RR, Fellows J, Meisner S, Olsen JK, Vestergaard M, Ajslev TA. A pilot study of a digital ostomy leakage notification system: impact on worry and quality of life. Br J Nurs. 2023 Mar 23;32(6):S4-S12. doi: 10.12968/bjon.2023.32.6.S4.
PubMed 36952372
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a Supporting Ostomy Product Intended for Leakage Detection
- ClinicalTrials.gov ID
- NCT04894084
- Acronym / sponsor ID
- CP321
- Conditions
- Stoma Ileostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Posted 1 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, open label study. Subjects are allocated to use test product for 3 weeks. Subjects will complete questionnaires at baseline (V1) and again after 3 weeks use of test product (V2). Comparative tests included: Baseline vs. follow-up measures.
| Arm | Type | Receives |
|---|---|---|
| Test product | Experimental | Device: CP321Subjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Have had a stoma for more than three months
- Have intact skin on the area used in the evaluation meaning no broken skin and only minor discoloration of the skin (assessed by investigator)
- Be able to use one of the five sensor layer sizes (i.e. Ø40, Ø50, Ø60, Ø70, Ø80 mm)
Key exclusion criteria (8 listed)
- Currently receiving or have within the past 2 month received radio- and/or chemotherapy
- Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
- Are pregnant or breastfeeding
- Participating in other interventional clinical investigations or have previously participated in this investigation. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this protocol.
- Known sensitivity towards test product
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP321The primary objective is to evaluate the system performance of the test product. This is done by asking subjects to answer questions throughout the study | Device | Test product |
Primary outcome
System Performance Accuracy of Pictures
Time frame: 21 days
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
19 secondary outcomes
Frequency of Leakage Onto Clothes Before and After Use of Test Product
Time frame: At V1 (baseline) and V2 (follow-up, Day 21)
Experience of Leakage Onto Clothes Compared to Only Using Usual Product
Time frame: V2 (follow-up, Day 21)
Reliability of Notifications
Time frame: V2 (follow-up, Day 21)
Ability to Move With Test Product
Time frame: V2 (follow-up, Day 21)
Subjects Worry of Leakage Before and After Use of Test Product
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
Time frame: V2 (follow-up, Day 21)
Confidence in Daily Life Compared to Only Using Usual Product
Time frame: V2 (follow-up, Day 21)
Feeling of Control With Test Product Compared to Only Using Usual Product
Time frame: V2 (follow-up, Day 21)
Control of Leakage Progression With Test Product Compared to Only Using Usual Product
Time frame: V2 (follow-up, Day 21)
Feeling of Security With Test Product Compared to Only Using Usual Product
Time frame: V2 (follow-up, Day 21)
Evaluation of Confidence to Increase Social Activities With Test Product Compared to Only Using Usual Product
Time frame: V2 (follow-up, Day 21)
Evaluation of Sleep With Test Product Compared to Only Using Usual Product
Time frame: V2 (follow-up, Day 21)
Confidence at Night With Test Product Compared to Only Using Usual Product
Time frame: V2 (follow-up, Day 21)
Evaluation of Users' Preference
Time frame: V2 (follow-up, Day 21)
Reason for Preference
Time frame: V2 (follow-up, Day 21)
Evaluation of Users' Peace of Mind With Test Product
Time frame: V2 (follow-up, Day 21)
To Evaluate Users' Assessment of QoL With Test Product Compared to Usual Product
Time frame: V2 (follow-up, Day 21)
Adhesive Residue to Skin
Time frame: V2 (follow-up, Day 21)
Adhesive Residue to Transmitter
Time frame: V2 (follow-up, Day 21)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36952372Brady RR, Fellows J, Meisner S, Olsen JK, Vestergaard M, Ajslev TA. A pilot study of a digital ostomy leakage notification system: impact on worry and quality of life. Br J Nurs. 2023 Mar 23;32(6):S4-S12. doi: 10.12968/bjon.2023.32.6.S4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Søren Meisner, MD principal investigator
Coloplast A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CP321 in people with Stoma Ileostomy, run by Coloplast A/S at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Performance Accuracy of Pictures (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04894084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.