Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Pa… (NCT02507726) | Clinical Trial Compass
CompletedNot Applicable
Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Patients With Enterostomy
France40 participantsStarted 2015-06
Plain-language summary
This study evaluates the performance of a new 1-piece ostomy convex appliance in patients with enterostomy.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* patient is at least 18 years old,
* patient having a colostomy or an ileostomy for at least 1 month,
* patient having a stoma's diameter inferior to 45 mm,
* patient having a flat or flushed or slightly retracted stoma,
* patient using currently a one-piece soft convex or standard ostomy appliance with closed or drainable bags,
* patient using a minimum of 1 product per day with closed pouches or minimum 1 product per two days with drainable pouches
* patient capable to apply and remove the pouch himself or with the help of a caregiver (except health care professional)
* patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
* patient agreeing to test investigational product during 14(±3) days.
* patient covered by social security
Exclusion Criteria:
* patient experiencing repeated leakages with his current appliance,
* patient receiving or having received, within the last month, chemotherapy or radiotherapy or corticotherapy,
* patient having a deeply retracted stoma,
* patient currently suffering from peristomal skin complications (bleeding or severe irritation or red and broken skin at the time of inclusion),
* patient already participating in another clinical study or who have previously participated in this investigation,
* pregnant or breast-feeding woman
What they're measuring
1
Flexima® Active Soft Convex ostomy appliance performance description in term of level of leakage under the skin protector