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

NCT05373888 | Unknown

• 1 other identifier: OPM-O-H-2005
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Enterostomy; Stoma Ileostomy; Stoma Colostomy

Keywords

enterostomy; colostomy; ileostomy; stoma; jejunostomy; stoma appliance

Outcome Measures

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)

  14 days

Study Arms (1)

Main

Enterostomy patients, including colostomates, ileostomates or jejunostomates.

Device: Flexima®/Softima® stoma bags

Interventions

Flexima®/Softima® stoma bags DEVICE

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)

Main

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Enterostomy patients, including colostomates, ileostomates or jejunostomates.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BBraun Medical SAS: lead

Study Sites (1)

Fundacion Jimenez Diaz

Madrid, Spain

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 13, 2022
• Study Start: April 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 13, 2022

Record last verified: 2022-05

Locations

ES (1)