Safety and Performance of Flexima®/Softima® Stoma Appliances in Enterostomy Patients

Stoma Ileostomy Clinical Trial

Official title:

Prospective, Non-interventional, Post-Market Clinical Follow-up Investigation of the Safety and Performance of Flexima®/Softima® Stoma Appliances in Enterostomy Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05373888
• Other study ID #: OPM-O-H-2005
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2022
• Source: BBraun Medical SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Details of the procedures performed at each visit follow.

#A ENROLMENT VISIT (Visit 1, onsite)

The following procedures will be performed:

• Informed consent

• Eligibility assessment

• Record demographics

• Record medical and surgical history (including stoma details)

• Record details of the appliance currently used, which could be different than a Flexima®/Softima®. However, participation in the investigation requires a Flexima®/Softima® appliance be used.

• Peristomal skin assessment (DET scoring)

• Discuss investigation requirements with the participant, including the need of adequately completing the patient's diary

• Start recording adverse events and concomitant medications

• B 14 (±3 DAY) DEVICE WEARING TIME (telephone follow-up)

During the wearing time, the following procedures will be done:

• The clinical site personnel will follow-up with the participants by telephone as required

• Participants will complete the patient's diary, which includes a record of appliance changes and assessment of leakages

• Record adverse events and concomitant medications (via telephone follow-up)

• C FINAL VISIT (Visit 2, onsite)

During the final visit, the following procedures will be done:

• Peristomal skin assessment (DET scoring)

• Participant evaluation of device performance (see 8.2.7)

• The responsible site personnel will review the patient's diary together with the patient. Any missing data will be discussed with the patient and, if possible, completed. In case it can't be completed, clarification notes explaining the reason for the missing data are to be added to the patient's diary (e.g. details forgotten)

• Record adverse events and concomitant medications

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enterostomy
• Stoma Colostomy
• Stoma Ileostomy

Intervention

Device:
• Flexima®/Softima® stoma bags
One piece stoma bags for enterostomates available as: Closed (flat and convex) Drainable with Roll'Up (flat and convex) High flow with tape outlet (flat)

Locations

Country	Name	City	State
Spain	Fundacion Jimenez Diaz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
BBraun Medical SAS

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with at least one adverse device effect (ADE) as judged by the clinician.	The primary variable is the number of patients with at least one adverse device effect (ADE) as judged by the clinician.; The occurrence of any of the following events in the peristomal skin may be considered related to the use of the stoma appliance (ie, ADEs): Allergic contact dermatitis; Mechanical dermatitis - trauma; Irritant-chemical dermatitis; Infectious conditions; Any other appliance related complication (as judged by the clinician)	14 days