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

NCT03108105 | Completed

• 1 other identifier: OPM-G-H-1604
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colostomy Stoma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

AOS-C2001-B

EXPERIMENTAL

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

Interventions

AOS-C2001-B DEVICE

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)

AOS-C2001-B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient experiencing repeated leakages with the usual pouching system
• 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

Sponsors & Collaborators

• BBraun Medical SAS: lead

Study Sites (1)

Elie CHOUILLARD

Poissy, 78100, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 11, 2017
• Study Start: June 1, 2017
• Primary Completion: November 7, 2017
• Study Completion: November 7, 2017
• Last Updated: April 24, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)