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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02602236
• Date of registration: 04/11/2015
• Prospective Registration: No
• Primary sponsor: BBraun Medical SAS
• Public title: Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy
• Scientific title: Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy
• Date of first enrolment: November 2015
• Target sample size: 31
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02602236
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Mahaut LECONTE, MD
• Affiliation: University Hospital of Paris - Cochin

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Colostomy

Intervention(s)

Device: AOS-C2000-B

Primary Outcome(s)

Description of efficacy in term of type of bag deployment and leakage prevention [Time Frame: At least 1 time per day during 14±3 days]

Secondary Outcome(s)

Ease of bag deployment [Time Frame: 14±3 days]

Investigational device adhesivity during wear time [Time Frame: 14±3 days]

Investigational device filter performance with undeployed bag [Time Frame: 14±3 days]

Investigational device wearing comfort [Time Frame: 14±3 days]

Investigational product bag ease of use of gas release button [Time Frame: 14±3 days]

Number of participants with Adverse Event as a measure of safety and tolerability [Time Frame: At baseline, at 5±3 days and 14±3 days]

Overall satisfaction questionnaire of the collection volume of the bag of the Investigational device [Time Frame: 14±3 days]

Overall satisfaction questionnaire with cap cover of the Investigational device [Time Frame: 14±3 days]

Overall security feeling questionnaire with the Investigational device [Time Frame: 14±3 days]

Overall satisfaction questionnaire with the Investigational device [Time Frame: 14±3 days]

Assessment of the quality of life with Stoma-QoL questionnaire [Time Frame: At baseline, at 5±3 days and 14±3 days]

Assessment questionnaire of willingness to use and the frequency of use in the future [Time Frame: 14±3 days]

Efficacy of Investigational device gas release button [Time Frame: 14±3 days]

General impression about body image during use of the investigational product [Time Frame: 14±3 days]

General impression about the investigational device before use [Time Frame: 14±3 days]

Noise during Investigational device wear time [Time Frame: 14±3 days]

Assessment of the investigational device wear time [Time Frame: 14±3 days]

Ease of special bag handling [Time Frame: 14±3 days]

Ease of control of gas release button [Time Frame: 14±3 days]

Investigational device filter performance with deployed bag [Time Frame: 14±3 days]

Assessment of use of accessories [Time Frame: At each bag change during 14±3 days]

Assessment questionnaire preference between the investigational device and usual appliance [Time Frame: 14±3 days]

Investigational device flexibility [Time Frame: 14±3 days]

Investigational product bag deployment reason [Time Frame: At each bag change during 14±3 days]

Peristomal skin evaluation with DET score scale [Time Frame: baseline and 5±3 days and 14±3 days]

Ease of base plate handling [Time Frame: 14±3 days]

Investigational device discretion [Time Frame: 14±3 days]

Overall satisfaction questionnaire regarding bag deployment of the Investigational device [Time Frame: 14±3 days]

Secondary ID(s)

2015-A00611-48

OPM-G-H-1401

Source(s) of Monetary Support

Please refer to primary and secondary sponsors