Study to Evaluate the Performance of a New 2-piece Ostomy Appliance vs. Flexima® 3S in Patients With Enterostomy

Last updated: June 19, 2018
Sponsor: BBraun Medical SAS
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03572673
OPM-G-H-1705
  • Ages > 18
  • All Genders

Study Summary

To compare the performance of the comparator Flexima 3S appliance to a new 2-piece appliance in patients with enterostomy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patient having a colostomy or an ileostomy for at least 1 month

  • patient currently using a flat appliance

  • patient wearing his appliance, on average, at least 5 days

  • patient with a stoma's diameter less than 65 mm

  • patient who agrees to participate in the evaluation and who have signed the informconsent

  • patient having a mental capacity to participate to the study (i.e. to understand thestudy and to answer to the questions)

Exclusion

Exclusion Criteria:

  • Patient currently suffering from peristomal skin complications (bleeding or red andbroken skin at the time of inclusion)

  • Patient receiving or having received, within the last month, chemotherapy orcorticotherapy

  • Patient already participating in another clinical study or who have previouslyparticipated in this investigation

  • Pregnant or breast-feeding woman

Study Design

Total Participants: 38
Study Start date:
May 08, 2018
Estimated Completion Date:
April 30, 2019

Connect with a study center

  • Hospital Selayang

    Batu Caves, 68100
    Malaysia

    Active - Recruiting

  • Hospital Canselor Tuanku Muhriz

    Kuala Lumpur, 56000
    Malaysia

    Active - Recruiting

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