Status:
UNKNOWN
Safety and Performance of Flexima®/Softima® Stoma Appliances in Enterostomy Patients
Lead Sponsor:
BBraun Medical SAS
Conditions:
Enterostomy
Stoma Ileostomy
Eligibility:
All Genders
18+ years
Brief Summary
The study is designed as a non-interventional, prospective, international, multi-center, post market follow-up investigation. The product under investigation will be used in routine clinical practice ...
Detailed Description
Details of the procedures performed at each visit follow. #A ENROLMENT VISIT (Visit 1, onsite) The following procedures will be performed: * Informed consent * Eligibility assessment * Record demog...
Eligibility Criteria
Inclusion
- Patients for whom the use of a Flexima®/Softima® appliance is indicated and has been decided within the regular planning of their treatment. Both, new users or users already using Flexima®/Softima® appliances are eligible for participation.
Exclusion
- Patients under 18 years old
- Patients who are mentally or linguistically unable to understand the aim of the investigation; or unable to comply with the investigation procedures.
- Patients taking part in another clinical investigation which could have an impact on the current investigation.
- Patient vulnerable. Vulnerable patients are adults unable to express their consent, patients under legal protection, patients deprived of their liberty by a judicial or administrative decision, patients subject to psychiatric care against their will and pregnant, parturient or breastfeeding women.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05373888
Start Date
April 1 2022
End Date
March 31 2023
Last Update
May 13 2022
Active Locations (1)
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1
Fundacion Jimenez Diaz
Madrid, Spain