Study on the Stoma Appliance Flexima®/Softima® 3S

Ostomy Clinical Trial

— KISSS  

Official title:

Non-Interventional, International, Post-Marketing Clinical Follow-up Study on the Stoma Appliance Flexima®/Softima® 3S

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03133585
• Other study ID #: OPM-O-H-1502
• Status: Recruiting
• Start date: August 23, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: April 2019
• Source: BBraun Medical SAS
• Contact: Ghislaine Martin
• Phone: 141107563
• Email: ghislaine.martin[@]bbraun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ostomy

Intervention

Device:
• 2 piece appliance for stomy
Use of the Flexima®/Softima® 3S during 6 months following the patient's usually frequency of appliance change

Locations

Country	Name	City	State
France	CHU Lapeyronie	Montpellier
France	Hopital Tenon	Paris	Ile De France

Sponsors (3)

Lead Sponsor	Collaborator
BBraun Medical SAS	EVAMED, VERTICAL

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation of 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. For each item, the patient will evaluated the product thanks to a 4 points scale question (very good (4)/good(3)/ poor(2)/ very poor(1))	the questions will be asked to the patient at each follow up visits (= at 1 month, 3 months and 6 months).Total Score will range from 3 to 12. A total score of 9 or more will define appropriate overall satisfaction.