Safety and Performance of Flexima®/Softima® Stoma Appliances in Enterostomy Patients
NCT ID: NCT05373888
Last Updated: 2022-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2022-04-01
2023-03-31
Brief Summary
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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.
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Detailed Description
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#A ENROLMENT VISIT (Visit 1, onsite)
The following procedures will be performed:
* Informed consent
* Eligibility assessment
* Record demographics
* Record medical and surgical history (including stoma details)
* Record details of the appliance currently used, which could be different than a Flexima®/Softima®. However, participation in the investigation requires a Flexima®/Softima® appliance be used.
* Peristomal skin assessment (DET scoring)
* Discuss investigation requirements with the participant, including the need of adequately completing the patient's diary
* Start recording adverse events and concomitant medications
* B 14 (±3 DAY) DEVICE WEARING TIME (telephone follow-up)
During the wearing time, the following procedures will be done:
* The clinical site personnel will follow-up with the participants by telephone as required
* Participants will complete the patient's diary, which includes a record of appliance changes and assessment of leakages
* Record adverse events and concomitant medications (via telephone follow-up)
* C FINAL VISIT (Visit 2, onsite)
During the final visit, the following procedures will be done:
* Peristomal skin assessment (DET scoring)
* Participant evaluation of device performance (see 8.2.7)
* The responsible site personnel will review the patient's diary together with the patient. Any missing data will be discussed with the patient and, if possible, completed. In case it can't be completed, clarification notes explaining the reason for the missing data are to be added to the patient's diary (e.g. details forgotten)
* Record adverse events and concomitant medications
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Main
Enterostomy patients, including colostomates, ileostomates or jejunostomates.
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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BBraun Medical SAS
INDUSTRY
Responsible Party
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Locations
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Fundacion Jimenez Diaz
Madrid, , Spain
Countries
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Facility Contacts
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Other Identifiers
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OPM-O-H-2005
Identifier Type: -
Identifier Source: org_study_id
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