Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy
NCT ID: NCT02602236
Last Updated: 2017-02-06
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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TERMINATED
NA
31 participants
INTERVENTIONAL
2015-11-30
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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AOS-C2000-B
A new 2-piece appliance composed with 2 parts : a base plate and an ostomy collection special pouch (1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day)
AOS-C2000-B
1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day
Interventions
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AOS-C2000-B
1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day
Eligibility Criteria
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Inclusion Criteria
* Patient having a colostomy with a diameter less than 30 mm for users of Ø 55 mm pouches or having a colostomy with a diameter less than 40 mm for users of Ø 65 mm pouches
* Patient having a colostomy for at least 1 month
* Patient using currently the two-piece flat ostomy appliance Flexima®/Softima® 3S for at least 2 weeks and being satisfied
* Patient having a stoma protusion smaller than or equal to 1.5 cm
* Patient capable to apply and remove the appliance 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 the new appliance during the training phase (5±3 days) and during the study device usage phase (14±3 days)
* Patient covered by social security
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, radiotherapy or corticotherapy
* Patient already participating in another clinical study or who have previously participated in this investigation
* Pregnant or breast-feeding woman
18 Years
ALL
No
Sponsors
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BBraun Medical SAS
INDUSTRY
Responsible Party
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Principal Investigators
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Mahaut LECONTE, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Paris - Cochin
Locations
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Centre Georges François Leclerc
Dijon, , France
Countries
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Other Identifiers
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2015-A00611-48
Identifier Type: OTHER
Identifier Source: secondary_id
OPM-G-H-1401
Identifier Type: -
Identifier Source: org_study_id
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