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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03108105

Enrollment

Registered

2017-04-11

Start date

2017-06-01

Completion date

2017-11-07

Last updated

2018-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colostomy Stoma

Brief summary

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

Interventions

DEVICEAOS-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)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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 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

Design outcomes

Primary

Measure	Time frame	Description
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 type of capsule cap cover removal

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026