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UNKNOWNNANCT03572673

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

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

Lead sponsor: BBraun Medical SAS•2 locations•View source on ClinicalTrials.gov

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Contacts

Aude Michaud

CONTACT

+33632542788 aude.michaud@bbraun.com

Sponsors

Lead Sponsor

BBraun Medical SAS

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

Exclusion Criteria

•Patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)
•Patient receiving or having received, within the last month, chemotherapy or corticotherapy
•Patient already participating in another clinical study or who have previously participated in this investigation
•Pregnant or breast-feeding woman

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 28, 2018Terms

Trial snapshot

StatusUNKNOWN

PhaseNA

Enrollment38

Start dateMay 2018

Last updatedJun 28, 2018

Condition

Locations shown

Hospital Selayang

Batu Caves

Hospital Canselor Tuanku Muhriz

Kuala Lumpur

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 28, 2018Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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