Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy

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

Study Overview

• Status: Terminated
• Conditions: Colostomy
• Intervention / Treatment: Device: AOS-C2000-B

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Centre Georges François Leclerc

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 currently the two-piece flat ostomy appliance Flexima®/Softima® 3S for at least 2 weeks and being satisfied
• 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 training phase (5±3 days) and during the study device usage 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-C2000-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-C2000-B; 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 term of type of bag deployment and leakage prevention	After each change of the investigational product, the patient will describe on a 3-point scale the type of deployment "manual", "spontaneous - in link with stools or gas", "spontaneous - no link with stools or gas"	At least 1 time per day during 14±3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peristomal skin evaluation with DET score scale		baseline and 5±3 days and 14±3 days
Investigational product bag deployment reason	Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)	At each bag change during 14±3 days
Ease of bag deployment	Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)	14±3 days
Ease of special bag handling	Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)	14±3 days
Investigational product bag ease of use of gas release button	Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)	14±3 days
Ease of control of gas release button	Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)	14±3 days
General impression about the investigational device before use	Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)	14±3 days
Investigational device wearing comfort	Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)	14±3 days
Investigational device flexibility	Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)	14±3 days
Investigational device discretion	Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)	14±3 days
Ease of base plate handling	Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)	14±3 days
Investigational device adhesivity during wear time	Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)	14±3 days
Investigational device filter performance with deployed bag	Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)	14±3 days
Investigational device filter performance with undeployed bag	Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)	14±3 days
Efficacy of Investigational device gas release button	Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)	14±3 days
Noise during Investigational device wear time	Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)	14±3 days
Overall satisfaction questionnaire of the collection volume of the bag of the Investigational device		14±3 days
Overall security feeling questionnaire with the Investigational device		14±3 days
Overall satisfaction questionnaire with the Investigational device		14±3 days
Overall satisfaction questionnaire regarding bag deployment of the Investigational device		14±3 days
Overall satisfaction questionnaire with cap cover of the Investigational device		14±3 days
General impression about body image during use of the investigational product	(4-points very satisfying to not at all satisfying)	14±3 days
Assessment questionnaire of willingness to use and the frequency of use in the future		14±3 days
Assessment of the investigational device wear time		14±3 days
Assessment questionnaire preference between the investigational device and usual appliance		14±3 days
Assessment of use of accessories	Choice between some accessories	At each bag change during 14±3 days
Assessment of the quality of life with Stoma-QoL questionnaire		At baseline, at 5±3 days and 14±3 days
Number of participants with Adverse Event as a measure of safety and tolerability		At baseline, at 5±3 days and 14±3 days

Collaborators and Investigators

• Sponsor: BBraun Medical SAS
• Investigators: Principal Investigator: Mahaut LECONTE, MD, University Hospital of Paris - Cochin

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: November 4, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimate): November 11, 2015

Study Record Updates

• Last Update Posted (Estimate): February 6, 2017
• Last Update Submitted That Met QC Criteria: February 3, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: OPM-G-H-1401; 2015-A00611-48 (Other Identifier: FRENCH HEALTH AUTORITY)