Status:
COMPLETED
Investigation of a Supporting Ostomy Product Intended for Leakage Detection
Lead Sponsor:
Coloplast A/S
Conditions:
Stoma Ileostomy
Eligibility:
All Genders
18+ years
Phase:
NA
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 th...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04894084
Start Date
April 29 2021
End Date
July 14 2021
Last Update
September 22 2023
Active Locations (1)
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1
Coloplast A/S
Humlebæk, Denmark, 3050