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

Colostomy Stoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03108105
• Other study ID #: OPM-G-H-1604
• Status: Completed
• Phase: N/A
• First received: April 5, 2017
• Last updated: April 23, 2018
• Start date: June 1, 2017
• Est. completion date: November 7, 2017

Study information

• Verified date: April 2018
• Source: BBraun Medical SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 7, 2017
• Est. primary completion date: November 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colostomy Stoma

Intervention

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)

Locations

Country	Name	City	State
France	Elie CHOUILLARD	Poissy

Sponsors (1)

Lead Sponsor	Collaborator
BBraun Medical SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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