Study on the Stoma Appliance Flexima®/Softima® 3S (KISSS)

B. Braun

Status: Unknown

Conditions: Ostomy

Treatments: Device: 2 piece appliance for stomy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03133585

OPM-O-H-1502

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• 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