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Status unknownNCT05373888Updated May 13, 2022

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

An observational study in Enterostomy, Stoma Ileostomy and Stoma Colostomy, sponsored by BBraun Medical SAS. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-13.

Sponsored by BBraun Medical SAS · Observational

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Enterostomy
  • Stoma Ileostomy
  • Stoma Colostomy

Keywords

  • enterostomy
  • colostomy
  • ileostomy
  • stoma
  • jejunostomy
  • stoma appliance
03

In context

Lead sponsor

BBraun Medical SAS is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Enterostomy patients, including colostomates, ileostomates or jejunostomates.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Main

    Enterostomy patients, including colostomates, ileostomates or jejunostomates.

    Device: Flexima®/Softima® stoma bags

Interventions

  • DeviceFlexima®/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)

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 14 days

07

Study locations

1 of 1 sites recruiting
  • Fundacion Jimenez Diaz
    Madrid, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05373888
Lead sponsor
BBraun Medical SAS
Responsible party
Sponsor
First posted
May 13, 2022
Start date
Apr 1, 2022
Primary completion
Mar 31, 2023 (estimated)
Completion
Mar 31, 2023 (estimated)
Last update
May 13, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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