Safety and Performance of Flexima®/Softima® Stoma Appliances in Enterostomy Patients (NCT05373888) | Clinical Trial Compass
UnknownNot Applicable
Safety and Performance of Flexima®/Softima® Stoma Appliances in Enterostomy Patients
Spain200 participantsStarted 2022-04-01
Plain-language 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 and according to Instructions for Use (IFU). The data obtained during routine clinical use will be documented in electronic Case Report Forms (eCRF).
The investigation will consist of an enrolment visit (Visit 1, or V1) and a final visit (Visit 2, or V2). The duration between the two visits is 14 (±3) days.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Number of patients with at least one adverse device effect (ADE) as judged by the clinician.