Status:
COMPLETED
Investigating the Performance of a New Adhesive Strip
Lead Sponsor:
Coloplast A/S
Conditions:
Ileostomy - Stoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study investigates the performance of a new adhesive
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 one year
- Have intact skin on the area used in the evaluation
- Has a stoma with a diameter up to (≤) 35 mm
- Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)
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
- Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
- Actively participating in other interventional clinical investigations or have previously participated in this investigation.
- 1. Exception: Participation in other Coloplast in-house clinical investigations are accepted under the circumstances of otherwise complying with the Inclusion and exclusion criteria of this protocol (CP265)
Key Trial Info
Start Date :
January 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2018
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03423134
Start Date
January 25 2018
End Date
February 20 2018
Last Update
February 1 2019
Active Locations (1)
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1
Coloplast A/S
Humlebæk, Denmark, 3050