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

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

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.

Study Overview

• Status: Unknown
• Conditions: Ostomy
• Intervention / Treatment: Device: 2 piece appliance for stomy

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34000
    • Recruiting
    • CHU Lapeyronie
    • Contact: Marie-Noelle Mrs Bernassau
  • Ile De France
    • Paris, Ile De France, France, 75020
      • Not yet recruiting
      • Hôpital Tenon
      • Contact: Daniel Mrs Chaumier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient with a Enterostomy or an urostomy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: BBraun Medical SAS
• Collaborators: EVAMED; VERTICAL
• Investigators: Principal Investigator: Danièle Chaumier, Hôpital Tenon, Paris, France

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2017
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: OPM-O-H-1502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No