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

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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