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

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

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

Study Overview

• Status: Completed
• Conditions: Colostomy Stoma
• Intervention / Treatment: Device: AOS-C2001-B

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poissy, France, 78100
    • Elie CHOUILLARD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AOS-C2001-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)	Device: AOS-C2001-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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of efficacy in terms of stool collection and leakage prevention	After each change of the investigational product, the patient will describe on a 4-point scale the type of capsule cap cover removal	At least 1 time per day during 14±3 days
Description of efficacy in terms of stool collection and leakage prevention	After each change of the investigational product, the patient will describe on a 4-point scale the level of leakage	At least 1 time per day during 14±3 days

Collaborators and Investigators

• Sponsor: BBraun Medical SAS

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): November 7, 2017
• Study Completion (Actual): November 7, 2017

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: OPM-G-H-1604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No