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

NCT05373888 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2022-05-13

No results posted yet for this 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.

Conditions

  • Enterostomy
  • Stoma Ileostomy
  • Stoma Colostomy

Interventions

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)

Sponsors & Collaborators

  • BBraun Medical SAS

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05373888 on ClinicalTrials.gov