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

Sponsor
BBraun Medical SAS (Industry)
Overall Status
Completed
CT.gov ID
NCT03108105
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
5.2
Actual Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: AOS-C2001-B
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Multicenter Pilot Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy
Actual Study Start Date :
Jun 1, 2017
Actual Primary Completion Date :
Nov 7, 2017
Actual Study Completion Date :
Nov 7, 2017

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Elie CHOUILLARD Poissy France 78100

Sponsors and Collaborators

  • BBraun Medical SAS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
BBraun Medical SAS
ClinicalTrials.gov Identifier:
NCT03108105
Other Study ID Numbers:
  • OPM-G-H-1604
First Posted:
Apr 11, 2017
Last Update Posted:
Apr 24, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 24, 2018