Investigation of a Supporting Ostomy Product Intended for Leakage Detection

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
Investigation of a Supporting Ostomy Product Intended for Leakage Detection

Conditions
-----------------
Stoma Ileostomy

Intervention / Treatment
-----------------
* Device: CP321


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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test product<br>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. | Device: CP321<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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? | 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 | 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 | 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 | V2 (follow-up, Day 21) | 
| Evaluation of Users' Preference | Q: Which product solution do you prefer? Own product - Own product with test product | 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 | 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 | 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 | 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 | 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 | V2 (follow-up, Day 21) |