The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
31
1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day
Centre Georges François Leclerc
Dijon, France
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"
Time frame: At least 1 time per day during 14±3 days
Peristomal skin evaluation with DET score scale
Time frame: 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)
Time frame: 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)
Time frame: 14±3 days
Ease of special bag handling
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Time frame: 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)
Time frame: 14±3 days
Ease of control of gas release button
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Time frame: 14±3 days
General impression about the investigational device before use
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Time frame: 14±3 days
Investigational device wearing comfort
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Time frame: 14±3 days
Investigational device flexibility
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Time frame: 14±3 days
Investigational device discretion
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Time frame: 14±3 days
Ease of base plate handling
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Time frame: 14±3 days
Investigational device adhesivity during wear time
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Time frame: 14±3 days
Investigational device filter performance with deployed bag
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Time frame: 14±3 days
Investigational device filter performance with undeployed bag
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Time frame: 14±3 days
Efficacy of Investigational device gas release button
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Time frame: 14±3 days
Noise during Investigational device wear time
Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
Time frame: 14±3 days
Overall satisfaction questionnaire of the collection volume of the bag 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
Overall satisfaction questionnaire regarding bag deployment of the Investigational device
Time frame: 14±3 days
Overall satisfaction questionnaire with cap cover of the Investigational device
Time frame: 14±3 days
General impression about body image during use of the investigational product
(4-points very satisfying to not at all satisfying)
Time frame: 14±3 days
Assessment questionnaire of willingness to use and the frequency of use in the future
Time frame: 14±3 days
Assessment of the investigational device wear time
Time frame: 14±3 days
Assessment questionnaire preference between the investigational device and usual appliance
Time frame: 14±3 days
Assessment of use of accessories
Choice between some accessories
Time frame: At each bag change during 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
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