Clinical trial NCT04894084: Investigation of a Supporting Ostomy Product Intended for Leakage Detection
Official title: Investigation of a Supporting Ostomy Product Intended for Leakage Detection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stoma Ileostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2021-05-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had a stoma for more than three months
4. Have intact skin on the area used in the evaluation meaning no broken skin and only minor discoloration of the skin (assessed by investigator)
5. Be able to use one of the five sensor layer sizes (i.e. Ø40, Ø50, Ø60, Ø70, Ø80 mm)
6. Ileo- or colostomists with liquid output (Bristol scale type 6-7).
7. Currently using a Coloplast product (1pc/2pc Flat/Convex/Concave) from e.g Assura/SenSura/SenSura Mio
8. Have self-reported problems with leakage\* (three times within 14 days)
9. Have worry of leakage 'to some, high or very high degree'
10. 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:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. 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.
5. Known sensitivity towards test product
6. Known sensitivity towards acrylate
7. Is using/have a pacemaker
8. Is using ostomy paste or ostomy powder

Primary outcomes:
measure: System Performance Accuracy of Pictures
timeFrame: 21 days
Secondary outcomes:
measure: Frequency of Leakage Onto Clothes Before and After Use of Test Product
timeFrame: At V1 (baseline) and V2 (follow-up, Day 21)
measure: Experience of Leakage Onto Clothes Compared to Only Using Usual Product
timeFrame: V2 (follow-up, Day 21)
measure: Reliability of Notifications
timeFrame: V2 (follow-up, Day 21)
measure: Ability to Move With Test Product
timeFrame: V2 (follow-up, Day 21)
measure: Subjects Worry of Leakage Before and After Use of Test Product
timeFrame: At V1 (baseline) and V2 (follow-up, Day 21)
measure: Confidence to Avoid Full Leakage With Test Product Compared to Only Using Usual Product
timeFrame: V2 (follow-up, Day 21)
measure: Confidence in Daily Life Compared to Only Using Usual Product
timeFrame: V2 (follow-up, Day 21)
measure: Feeling of Control With Test Product Compared to Only Using Usual Product
timeFrame: V2 (follow-up, Day 21)
measure: Control of Leakage Progression With Test Product Compared to Only Using Usual Product
timeFrame: V2 (follow-up, Day 21)
measure: Feeling of Security With Test Product Compared to Only Using Usual Product
timeFrame: V2 (follow-up, Day 21)
measure: Evaluation of Confidence to Increase Social Activities With Test Product Compared to Only Using Usual Product
timeFrame: V2 (follow-up, Day 21)
measure: Evaluation of Sleep With Test Product Compared to Only Using Usual Product
timeFrame: V2 (follow-up, Day 21)
measure: Confidence at Night With Test Product Compared to Only Using Usual Product
timeFrame: V2 (follow-up, Day 21)
measure: Evaluation of Users' Preference
timeFrame: V2 (follow-up, Day 21)
measure: Reason for Preference
timeFrame: V2 (follow-up, Day 21)
measure: Evaluation of Users' Peace of Mind With Test Product
timeFrame: V2 (follow-up, Day 21)
measure: To Evaluate Users' Assessment of QoL With Test Product Compared to Usual Product
timeFrame: V2 (follow-up, Day 21)
measure: Adhesive Residue to Skin
timeFrame: V2 (follow-up, Day 21)
measure: Adhesive Residue to Transmitter
timeFrame: V2 (follow-up, Day 21)
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Coloplast A/S
name: Søren Meisner, MD
role: PRINCIPAL_INVESTIGATOR
References: