Investigation of Patient Benefits With a New Supporting Ostomy Product and Support Service in Patients With a Newly Stoma Formation

Study Overview
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Brief Summary
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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.

Official Title
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Investigation of Patient Benefits With a New Supporting Ostomy Product and Support Service in Patients With a Newly Stoma Formation

Conditions
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Stoma Ileostomy

Intervention / Treatment
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* Device: Heylo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Test product - new supporting ostomy product and support service<br>The arm includes the newly developed ostomy support product togethter with a support service | Device: Heylo<br>* Test of the supporting product (test product) for a 12 weeks period. No measurement will be conducted. All endpoints are captured via surveys send to the subjects every 14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of times with stoma effluent leakage outside the baseplate (e.g. onto clothes or bedsheets) within the last 2 weeks | Survey question: Subjects are ask to think 2 weeks back | Every second week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Self-management | Patient Activation Measure (PAM) score | Every second week | 
| Leakage related quality of life | OLI score (Ostomy Leakage Impact score | Every second week | 
| Health Related Quality of Life | EQ5D-5L | Every second week |