Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy

B. Braun

Status: Terminated

Conditions: Colostomy

Treatments: Device: AOS-C2000-B

Study type: Interventional

Funder types: Industry

Identifiers

NCT02602236

OPM-G-H-1401

2015-A00611-48 (Other Identifier)

Details and patient eligibility

About

The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is at least 18 years old
• 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 experiencing repeated leakages with the usual pouching system
• 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

AOS-C2000-B

Experimental group

Description:

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)

Treatment:

Device: AOS-C2000-B