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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Enterostomy; Stoma Ileostomy; Stoma Colostomy
• Intervention / Treatment: Device: Flexima®/Softima® stoma bags

Detailed 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

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Recruiting
    • Fundación Jiménez Díaz
    • Contact: Yolanda Ortega Perez; Phone Number: 0034 91 550 48 00; Email: contacto@fjd.es

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

Enterostomy patients, including colostomates, ileostomates or jejunostomates.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Main; Enterostomy patients, including colostomates, ileostomates or jejunostomates.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: BBraun Medical SAS

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: ileostomy; colostomy; jejunostomy; enterostomy; stoma; stoma appliance
• Other Study ID Numbers: OPM-O-H-2005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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