Colostomy Stoma, Ileostomy - Stoma
Conditions
Brief 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 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.
Interventions
DEVICEHeylo
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.
DEVICEStandard of Care
Standard of Care is the ostomy products (baseplate and bag) that the subject normally uses
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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) * 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emotional Impact Score (Scale From 0-100) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participation in Society Domain Score (Scale From 0-100) | 8 weeks | 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Due to the cross-over study design, all participants were randomized to receive all interventions. Baseline data has therefore been reported for all 'All Study Participants' being part of the Intention-to-Treat Population. | 139 |
| Total | 139 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Continuous | 50.7 years STANDARD_DEVIATION 13.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 139 participants | — |
| Sex: Female, Male Female | 71 Participants | — |
| Sex: Female, Male Male | 68 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 144 | 2 / 144 |
| other Total, other adverse events | 5 / 144 | 0 / 144 |
| serious Total, serious adverse events | 3 / 144 | 4 / 144 |
Outcome results
Primary
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.
Time frame: 8 weeks
Population: The intention-to-treat (ITT) population (full analysis set) was constituted of all randomized subjects with valid informed consent who had been exposed to at least one product, and with information on at least one endpoint.~Heylo --\> Standard of Care: Analyzed (n=68) / Excluded from analysis (n=4) (Reasons: Only baseline data (n=4)).~Standard of Care --\> Heylo: Analyzed (n=71) / Excluded from analysis (n=1) (Reason: Only baseline data (n=1)).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Test Product - Heylo | Emotional Impact Score (Scale From 0-100) | 73.4 score on a scale |
| Standard of Care | Emotional Impact Score (Scale From 0-100) | 62.0 score on a scale |
p-value: <0.00195% CI: [7.83, 15.01]Mixed Models Analysis
Secondary
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.
Time frame: 8 weeks
Population: The intention-to-treat (ITT) population (full analysis set) was constituted of all randomized subjects with valid informed consent who had been exposed to at least one product, and with information on at least one endpoint.~Heylo --\> Standard of Care: Analyzed (n=68) / Excluded from analysis (n=4) (Reasons: Only baseline data (n=4)).~Standard of Care --\> Heylo: Analyzed (n=71) / Excluded from analysis (n=1) (Reason: Only baseline data (n=1)).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Test Product - Heylo | Participation in Society Domain Score (Scale From 0-100) | 33.0 score on a scale |
| Standard of Care | Participation in Society Domain Score (Scale From 0-100) | 37.1 score on a scale |
p-value: 0.00195% CI: [-6.69, -1.63]Mixed Models Analysis