Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy
- Conditions
- Colostomy
- Interventions
- Device: AOS-C2000-B
- Registration Number
- NCT02602236
- Lead Sponsor
- BBraun Medical SAS
- Brief Summary
The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 31
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AOS-C2000-B 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)
- Primary Outcome Measures
Name Time Method Description of efficacy in term of type of bag deployment 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 3-point scale the type of deployment "manual", "spontaneous - in link with stools or gas", "spontaneous - no link with stools or gas"
- Secondary Outcome Measures
Name Time Method Peristomal skin evaluation with DET score scale baseline and 5±3 days and 14±3 days Investigational product bag deployment reason At each bag change during 14±3 days Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Investigational device adhesivity during wear time 14±3 days Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Overall security feeling questionnaire with the Investigational device 14±3 days Overall satisfaction questionnaire with cap cover of the Investigational device 14±3 days Ease of bag deployment 14±3 days Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Ease of control of gas release button 14±3 days Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Investigational device flexibility 14±3 days Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
General impression about body image during use of the investigational product 14±3 days (4-points very satisfying to not at all satisfying)
Assessment of the investigational device wear time 14±3 days Assessment questionnaire preference between the investigational device and usual appliance 14±3 days Investigational device discretion 14±3 days Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Ease of base plate handling 14±3 days Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Investigational device filter performance with undeployed bag 14±3 days Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Overall satisfaction questionnaire with the Investigational device 14±3 days Assessment questionnaire of willingness to use and the frequency of use in the future 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 Ease of special bag handling 14±3 days Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Investigational device wearing comfort 14±3 days Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Investigational device filter performance with deployed bag 14±3 days Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Efficacy of Investigational device gas release button 14±3 days Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Overall satisfaction questionnaire regarding bag deployment of the Investigational device 14±3 days Investigational product bag ease of use of gas release button 14±3 days Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
General impression about the investigational device before use 14±3 days Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Noise during Investigational device wear time 14±3 days Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Overall satisfaction questionnaire of the collection volume of the bag of the Investigational device 14±3 days Assessment of use of accessories At each bag change during 14±3 days Choice between some accessories
Assessment of the quality of life with Stoma-QoL questionnaire At baseline, at 5±3 days and 14±3 days
Trial Locations
- Locations (1)
Centre Georges François Leclerc
🇫🇷Dijon, France