Stoma IleostomyNCT05135754
Investigation of Patient Benefits With a New Supporting Ostomy Product in Patients With a Newly Stoma Formation
A study testing Heylo in people with Stoma Ileostomy and Stoma Colostomy, run by Coloplast A/S at 10 sites in United Kingdom.
Trial summary
People with intestinal stomas 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 called Heylo™, which has an adhesive sensor layer that should be placed underneath the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma Ileostomy, Stoma Colostomy
- What is being tested?
- Heylo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 10 sitesUnited Kingdom
- Study dates
- 25 Nov 2021to 22 Aug 2022
- 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 provide written informed consent.
- Be at least 18 years of age and have full capacity.
- Have had their stoma for less than 9 months.
- Have intact skin on the peristomal area (assessed by investigator)
- Be able to use one of the five test products (i.e. Ø40, Ø50, Ø60, Ø70, Ø80 mm)
- Ileo- or colostomists with liquid and/or mushy output (Bristol scale type 5-7)
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- Is willing to refrain from use of paste and protective sheets.
- Have a smartphone applicable for the HeyloTM app.
- Have been self-managing stoma appliance for at least 14 days.
- Are able to follow study procedures for 3 months (assessed by investigator)
- Are willing to receive their ostomy products through Coloplast Charter for the duration of the study.
Who cannot join
- Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
- Is breastfeeding.
- Is pregnant based on urine pregnancy test.
- Enrolled in another current research study or have previously participated in this investigation.
- Has known hypersensitivity towards any of the products used in the investigation.
- Is using/have a pacemaker.
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- Has a complicated stoma at baseline (dehiscence/prolapse/hernia)
- Has limited life expectancy or receive palliative care.
- Has stage 4 cancer.
- Having more than one stoma synchronously
- Having ongoing non-healed abdominal wounds
- Reoperation / stoma reversal planned during the study period.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United Kingdom10 sites
Southmead/North Bristol NHS Trust
Bristol
Chelsea & Westminster Hospital
Chelsea
Devon/Royal Devon and Exeter NHS Foundation Trust
Exeter
Norfolk/James Paget University Hospitals NHS Foundation Trust
Great Yarmouth
Leeds/Leeds Teaching Hospitals NHS Trust
Leeds
Illingworth
Manchester
Middlesbrough/South Tees NHS trust, James Cook University Hospital
Middlesbrough
Newcastle University/The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, NE3 3HD
Petersborough/ North West Anglia NHS Foundation trust, Petersborough City Hospital
Peterborough
Preston/Lancashire Teaching Hospitals NHS Trust, Royal Preston Hospital
Preston
About this study
Official title: Investigation of Patient Benefits With a New Supporting Ostomy Product and Support Service in Patients With a Newly Stoma Formation
People with intestinal stomas 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 called Heylo™, which has an adhesive sensor layer that should be placed underneath the baseplate. The sensor layer consists of an electronic sensor system that continuously detects moisture and output leakage underneath the baseplate. A transmitter connected to the sensor layer continuously evaluates the incoming information and sends a status to a smartphone software application, which based on a predefined flow decides which information to deliver to the user about the baseplate status.
- Conditions
- Stoma Ileostomy, Stoma Colostomy
- Being tested
- Heylo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeyloDevice
Test of the supporting product (test product) for a 12 weeks period. No additional intervention will be conducted. A few follow up nurse calls to assess few endpoints together with subject. All remaining endpoints are captured via surveys send to the subjects every 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Test product - new supporting ostomy product and support service | Other | The arm includes the newly developed supporting ostomy product (leakage notification system Heylo) used together with a support service Receives: Device: Heylo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Times With Stoma Effluent Leakage Outside the Baseplate (e.g. Onto Clothes or Bedsheets) Within the Last 2 Weeks
Survey question: Think back on the last 2 weeks; how many times have you experienced stoma effluent leakage outside the baseplate (e.g. onto clothes or bedsheets)?
Measured: Baseline (Day 0) and Final Evaluation (Week 12)
Secondary outcomes (6)
Patient Self-management
Patient Activation Measure (PAM) score The Patient Activation Measurement (PAM) is scored on a scale ranging from 0 to 100.
Individuals who score high on this instrument typically understand the importance of taking a pro-active role in managing their health and have the skills and confidence to do so.
Measured: Baseline (Day 0) and Final Evaluation (Week 12)
Ostomy Leakage Impact Tool - 'Emotional Impact' Domain
Leakage-related quality of life. The Ostomy Leakage Impact (OLI) tool consists of 22 item questions, which are grouped in three domains. The three domains concern the impact of stoma leakage on (1) 'emotional' aspects, (2) 'usual and social activities', and (3) 'coping and in control'. Each domain has a score ranging from 0-100. A score of 100 equals no impact and a score of 0 represents full negative impact, thus a higher score means that subjects are less impacted from leakage in their daily life.
Measured: Baseline (Day 0) and Final Evaluation (Week 12)
Ostomy Leakage Impact Tool - 'Usual and Social Activities' Domain
Leakage-related quality of life. The Ostomy Leakage Impact (OLI) tool consists of 22 item questions, which are grouped in three domains. The three domains concern the impact of stoma leakage on (1) 'emotional' aspects, (2) 'usual and social activities', and (3) 'coping and in control'. Each domain has a score ranging from 0-100. A score of 100 equals no impact and a score of 0 represents full negative impact, thus a higher score means that subjects are less impacted from leakage in their daily life.
Measured: Baseline (Day 0) and Final Evaluation (Week 12)
Ostomy Leakage Impact Tool - 'Coping and in Control' Domain
Leakage-related quality of life. The Ostomy Leakage Impact (OLI) tool consists of 22 item questions, which are grouped in three domains. The three domains concern the impact of stoma leakage on (1) 'emotional' aspects, (2) 'usual and social activities', and (3) 'coping and in control'. Each domain has a score ranging from 0-100. A score of 100 equals no impact and a score of 0 represents full negative impact, thus a higher score means that subjects are less impacted from leakage in their daily life.
Measured: Baseline (Day 0) and Final Evaluation (Week 12)
Health Related Quality of Life
The EQ-5D-5L instrument consists of five dimensions with five predetermined levels of response that is used to generate a health state profile, which then can be assigned a summary index score. Translation of health states and index scores are based on the specific value set for United Kingdom.
The index scores based on the value set for United Kingdom ranges from -0.285 to 1.
Index score of -0.285 is the worst health state. Index score of 1 is the best health state.
Measured: Baseline (Day 0) and Final Evaluation (Week 12)
EQ-5D-5L Visual Analogue Scale (VAS)
Subjects rate their perceived health from 0 (worst imaginable health) to 100 (best imaginable health).
Measured: Baseline (Day 0) and Final Evaluation (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start25 Nov 2021
- Primary completion22 Aug 2022
- Study completion22 Aug 2022
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 (2)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
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Brady, Principal investigator, Newcastle-upon-Tyne Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135754
- Sponsor's protocol ID
- CP340
- Status last verified
- Apr 2024
- First submitted
- 27 Oct 2021
- Last updated
- 21 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brady RR, Sheard D, Alty M, Vestergaard M, Boisen EB, Ainsworth R, Hansen HD, Ajslev TA. Novel digital leakage notification system can promote better stoma management routines: a multicentre clinical trial. Br J Nurs. 2025 Jan 13;34(1):14-22. doi: 10.12968/bjon.2023.0278.
PubMed 39792106Brady RRW, Sheard D, Alty M, Vestergaard M, Boisen EB, Ainsworth R, Hansen HD, Ajslev TA. Evaluating the Effect of a Novel Digital Ostomy Device on Leakage Incidents, Quality of Life, Mental Well-Being, and Patient Self-Care: An Interventional, Multicentre Clinical Trial. J Clin Med. 2024 Sep 24;13(19):5673. doi: 10.3390/jcm13195673.
PubMed 39407731
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Patient Benefits With a New Supporting Ostomy Product and Support Service in Patients With a Newly Stoma Formation
- ClinicalTrials.gov ID
- NCT05135754
- Acronym / sponsor ID
- CP340
- Conditions
- Stoma Ileostomy, Stoma Colostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 26 Nov 2021 (actual)
- Results
- Posted 21 Aug 2024
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 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 called Heylo™, which has an adhesive sensor layer that should be placed underneath the baseplate. The sensor layer consists of an electronic sensor system that continuously detects moisture and output leakage underneath the baseplate. A transmitter connected to the sensor layer continuously evaluates the incoming information and sends a status to a smartphone software application, which based on a predefined flow decides which information to deliver to the user about the baseplate status.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test product - new supporting ostomy product and support service | Other | Device: HeyloThe arm includes the newly developed supporting ostomy product (leakage notification system Heylo) used together with a support service |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have provide written informed consent.
- Be at least 18 years of age and have full capacity.
- Have had their stoma for less than 9 months.
- Have intact skin on the peristomal area (assessed by investigator)
- Be able to use one of the five test products (i.e. Ø40, Ø50, Ø60, Ø70, Ø80 mm)
Key exclusion criteria (12 listed)
- Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
- Is breastfeeding.
- Is pregnant based on urine pregnancy test.
- Enrolled in another current research study or have previously participated in this investigation.
- Has known hypersensitivity towards any of the products used in the investigation.
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 |
|---|---|---|
| HeyloTest of the supporting product (test product) for a 12 weeks period. No additional intervention will be conducted. A few follow up nurse calls to assess few endpoints together with subject. All remaining endpoints are captured via surveys send to the subjects every 14 days. | Device | Test product - new supporting ostomy product and support service |
Primary outcome
Number of Times With Stoma Effluent Leakage Outside the Baseplate (e.g. Onto Clothes or Bedsheets) Within the Last 2 Weeks
Time frame: Baseline (Day 0) and Final Evaluation (Week 12)
Survey question: Think back on the last 2 weeks; how many times have you experienced stoma effluent leakage outside the baseplate (e.g. onto clothes or bedsheets)?
6 secondary outcomes
Patient Self-management
Time frame: Baseline (Day 0) and Final Evaluation (Week 12)
Ostomy Leakage Impact Tool - 'Emotional Impact' Domain
Time frame: Baseline (Day 0) and Final Evaluation (Week 12)
Ostomy Leakage Impact Tool - 'Usual and Social Activities' Domain
Time frame: Baseline (Day 0) and Final Evaluation (Week 12)
Ostomy Leakage Impact Tool - 'Coping and in Control' Domain
Time frame: Baseline (Day 0) and Final Evaluation (Week 12)
Health Related Quality of Life
Time frame: Baseline (Day 0) and Final Evaluation (Week 12)
EQ-5D-5L Visual Analogue Scale (VAS)
Time frame: Baseline (Day 0) and Final Evaluation (Week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39792106Brady RR, Sheard D, Alty M, Vestergaard M, Boisen EB, Ainsworth R, Hansen HD, Ajslev TA. Novel digital leakage notification system can promote better stoma management routines: a multicentre clinical trial. Br J Nurs. 2025 Jan 13;34(1):14-22. doi: 10.12968/bjon.2023.0278.
- Derived from this study: PubMed 39407731Brady RRW, Sheard D, Alty M, Vestergaard M, Boisen EB, Ainsworth R, Hansen HD, Ajslev TA. Evaluating the Effect of a Novel Digital Ostomy Device on Leakage Incidents, Quality of Life, Mental Well-Being, and Patient Self-Care: An Interventional, Multicentre Clinical Trial. J Clin Med. 2024 Sep 24;13(19):5673. doi: 10.3390/jcm13195673.
- 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.
Richard Brady principal investigator
Newcastle-upon-Tyne Hospitals NHS Trust
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heylo in people with Stoma Ileostomy and Stoma Colostomy, run by Coloplast A/S at 10 sites in United Kingdom.
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 11 inclusion and 12 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 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom. 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 21 Aug 2024). 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?
Number of Times With Stoma Effluent Leakage Outside the Baseplate (e.g. Onto Clothes or Bedsheets) Within the Last 2 Weeks (time frame: Baseline (Day 0) and Final Evaluation (Week 12)). 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 NCT05135754, which also lists 2 linked publications.
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 21 Aug 2024.