Multicenter Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy

Not Applicable

Completed

• Conditions: Colostomy Stoma

• Registration Number: NCT03108105
• Lead Sponsor: BBraun Medical SAS

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-11
• Study Start: 2017-06-01
• Primary Completion: 2017-11-07
• Study Completion: 2017-11-07
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-23
• Last Update Posted: 2018-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 a flat ostomy appliance
• 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 evaluation 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Description of efficacy in terms of stool collection and leakage prevention	At least 1 time per day during 14±3 days	After each change of the investigational product, the patient will describe on a 4-point scale the level of leakage

Trial Locations

Locations (1)

Elie CHOUILLARD; 🇫🇷 Poissy, France