Informations générales (source: ClinicalTrials.gov)

NCT03133585 Statut inconnu
Non-Interventional, International, Post-Marketing Clinical Follow-up Study on the Stoma Appliance Flexima®/Softima® 3S (KISSS)
Observational
BBraun Medical SAS (Voir sur ClinicalTrials)
août 2017
juin 2021
29 juin 2024
To evaluate the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up. The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S.
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Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Tenon Daniel Mrs Chaumier Recrutement non commencé Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU Lapeyronie - 34000 - Montpellier - France Marie-Noelle Mrs Bernassau En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- Patient is at least 18 years old

- Patient who has had a colostomy or an ileostomy or a jejunostomy or an urostomy for
at least 1 month

- Patient agreeing to participate to the study and having signed the informed consent
form/information letter in accordance with local requirements

- Patient for whom the use of Flexima®/Softima® 3S has already been decided within the
regular planning of his treatment


- Patient with cognitive problems, according to the investigator, preventing him from
answering a questionnaire or for whom the evaluation could be a problem

- Patient taking part in another clinical evaluation

- Patient having more than one stomy

- Patient vulnerable and under legal protection

- Patient having had an known allergy to one of the components of the appliance

- Patient previously using Flexima®/Softima® 3S