Ileostomy - StomaNCT05200416
Investigation of Heylo, a Novel App Driven Digital Supporting Ostomy Product
A study testing Heylo in people with Ileostomy - Stoma and Colostomy Stoma, run by Coloplast A/S at 1 site in Germany.
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
- Ileostomy - Stoma, Colostomy Stoma
- What is being tested?
- Heylo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteGermany
- Study dates
- 13 Jan 2022to 4 Nov 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
- Has given written consent to participate by signing the Informed Consent Signature Form.
- Is at least 18 years of age and has full legal capacity.
- Has an ileostomy or colostomy with consistent liquid/mushy fecal output (5-7 Bristol scale*)
- Is able to use one of the five test products (i.e. Ø40, Ø50, Ø60, Ø70, Ø80 mm).
- Has experienced leakage under the baseplate at least three times within the last fourteen days. Leakage defined as output seeping under the baseplate"
- Has worry about leakage to "some degree, high degree, or very high degree" (on a five-point Likert scale: Very low degree/Not at all, Low degree, some degree, High degree, very high degree)
Show all 9Show fewer
- Is willing to refrain from use of ostomy paste.
- Has a smartphone compatible with the Heylo™ application
- Is able to follow study procedures for 4 months (assessed by investigator or delegate)
Who cannot join
- Is participating in other clinical investigations or has previously participated in this investigation
- Is pregnant or breastfeeding
- Has known hypersensitivity towards any of the products used in the investigation
- Is using/ has a pacemaker
Trial locations and contacts
1 site in 1 country.
Germany1 site
Peter C. Ambe
Bergisch Gladbach, Bergisch Gladbach,Nordrhein-Westfalen, 51429
About this study
Official title: A Randomized Cross-over Trial Investigating Heylo, a Novel App Driven Digital Supporting Ostomy Product
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.
The overall aim of this clinical investigation is to evaluate the benefits of the new supporting product, Heylo compared to Standard of Care.
Read the detailed description
The Investigational device - Heylo, is already CE-marked.
The investigation is an open-labelled, randomized cross-over trial with two test periods evaluating Heylo and Standard of Care.
In total 144 subjects having an ileostomy or an colostomy will be included and randomized.
- Conditions
- Ileostomy - Stoma, Colostomy Stoma
- Being tested
- Heylo, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeyloDevice
Heylo is used in combination with the ostomy baseplate usually used by the subjects. It will detect and notify the subject of the occurrence of output leakage under an ostomy baseplate.
Standard of CareDevice
Standard of Care is the ostomy products (baseplate and bag) that the subject normally uses
| Study group | Role | What they receive |
|---|---|---|
| Test Product - Heylo | Experimental | The arm includes the test product Heylo Receives: Device: Heylo; Device: Standard of Care |
| Standard of Care | Active comparator | The arm includes Standard of Care Receives: Device: Heylo; Device: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional Impact Score (Scale From 0-100)
Measured by the validated OLI scale evaluated at the end of each test period. The questionnaire regarding Emotional impact contains 10 questions where the 4 answer options are: All of the time, Often, Sometimes and Rarely or never, which can be converted into a combined numerical score. The scale ranges from 0-100, where a score of 100 equals no impact and a score of 0 represents full impact.
Measured: 8 weeks
Secondary outcomes (1)
Participation in Society Domain Score (Scale From 0-100)
Measured by WHODAS 2.0 evaluated at the end of each test period. The questionnaire regarding Participation in society contains 11 questions where the 5 answer options are: None, Mild, Moderate, Severe and Extreme or cannot do, which can be converted into a combined domain score. Each domain has a range of 0-100, where low scores equal better health and high scores indicate greater disability.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start13 Jan 2022
- Primary completion4 Nov 2022
- Study completion4 Nov 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 (1)Papers the sponsor has linked to this study.
- Other trials for Ileostomy - StomaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter C. Ambe, Dr.med, Principal investigator, GFO Kliniken Rhein Berg, Vinzenz Pallotti Hospital, 51429 Bergisch Gladbach-Bensberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200416
- Sponsor's protocol ID
- CP345
- Status last verified
- Dec 2024
- First submitted
- 7 Jan 2022
- Last updated
- 23 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ambe PC, Brunckhorst E, Hansen HD, Gotfredsen JL, Vestergaard M, Ajslev TA. Effect of a Novel Digital Leakage Notification System (Heylo) for Ostomy Care on Quality of Life and Burden of Living With an Intestinal Ostomy: The ASSISTER Trial, A Randomized Controlled Cross-Over Trial. Mayo Clin Proc Digit Health. 2023 Sep 1;1(3):438-449. doi: 10.1016/j.mcpdig.2023.06.013. eCollection 2023 Sep.
PubMed 40206623
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cross-over Trial Investigating Heylo, a Novel App Driven Digital Supporting Ostomy Product
- ClinicalTrials.gov ID
- NCT05200416
- Acronym / sponsor ID
- CP345
- Conditions
- Ileostomy - Stoma, Colostomy Stoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Posted 23 Jan 2025
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.
The overall aim of this clinical investigation is to evaluate the benefits of the new supporting product, Heylo compared to Standard of Care.
Detailed description
The Investigational device - Heylo, is already CE-marked.
The investigation is an open-labelled, randomized cross-over trial with two test periods evaluating Heylo and Standard of Care.
In total 144 subjects having an ileostomy or an colostomy will be included and randomized.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Product - Heylo | Experimental | Device: Heylo, Device: Standard of CareThe arm includes the test product Heylo |
| Standard of Care | Active comparator | Device: Heylo, Device: Standard of CareThe arm includes Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Has given written consent to participate by signing the Informed Consent Signature Form.
- Is at least 18 years of age and has full legal capacity.
- Has an ileostomy or colostomy with consistent liquid/mushy fecal output (5-7 Bristol scale*)
- Is able to use one of the five test products (i.e. Ø40, Ø50, Ø60, Ø70, Ø80 mm).
- Has experienced leakage under the baseplate at least three times within the last fourteen days. Leakage defined as output seeping under the baseplate"
Key exclusion criteria (4 listed)
- Is participating in other clinical investigations or has previously participated in this investigation
- Is pregnant or breastfeeding
- Has known hypersensitivity towards any of the products used in the investigation
- Is using/ has a pacemaker
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 |
|---|---|---|
| HeyloHeylo is used in combination with the ostomy baseplate usually used by the subjects. It will detect and notify the subject of the occurrence of output leakage under an ostomy baseplate. | Device | Standard of Care, Test Product - Heylo |
| Standard of CareStandard of Care is the ostomy products (baseplate and bag) that the subject normally uses | Device | Standard of Care, Test Product - Heylo |
Primary outcome
Emotional Impact Score (Scale From 0-100)
Time frame: 8 weeks
Measured by the validated OLI scale evaluated at the end of each test period. The questionnaire regarding Emotional impact contains 10 questions where the 4 answer options are: All of the time, Often, Sometimes and Rarely or never, which can be converted into a combined numerical score. The scale ranges from 0-100, where a score of 100 equals no impact and a score of 0 represents full impact.
1 secondary outcome
Participation in Society Domain Score (Scale From 0-100)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40206623Ambe PC, Brunckhorst E, Hansen HD, Gotfredsen JL, Vestergaard M, Ajslev TA. Effect of a Novel Digital Leakage Notification System (Heylo) for Ostomy Care on Quality of Life and Burden of Living With an Intestinal Ostomy: The ASSISTER Trial, A Randomized Controlled Cross-Over Trial. Mayo Clin Proc Digit Health. 2023 Sep 1;1(3):438-449. doi: 10.1016/j.mcpdig.2023.06.013. eCollection 2023 Sep.
- 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.
Peter C. Ambe, Dr.med principal investigator
GFO Kliniken Rhein Berg, Vinzenz Pallotti Hospital, 51429 Bergisch Gladbach-Bensberg, Germany
1 site 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 Ileostomy - Stoma and Colostomy Stoma, run by Coloplast A/S at 1 site in Germany.
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 9 inclusion and 4 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 23 Jan 2025. 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 Germany. 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 23 Jan 2025). 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?
Emotional Impact Score (Scale From 0-100) (time frame: 8 weeks). 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 NCT05200416, 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 23 Jan 2025.