Clinical trial NCT02602236: Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy
Official title: Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colostomy
Lead sponsor: BBraun Medical SAS
Sponsor class: INDUSTRY
First posted: 2015-11-11
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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


Eligibility 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

Primary outcomes:
measure: Description of efficacy in term of type of bag deployment and leakage prevention
timeFrame: At least 1 time per day during 14±3 days
Secondary outcomes:
measure: Peristomal skin evaluation with DET score scale
timeFrame: baseline and 5±3 days and 14±3 days
measure: Investigational product bag deployment reason
timeFrame: At each bag change during 14±3 days
measure: Ease of bag deployment
timeFrame: 14±3 days
measure: Ease of special bag handling
timeFrame: 14±3 days
measure: Investigational product bag ease of use of gas release button
timeFrame: 14±3 days
measure: Ease of control of gas release button
timeFrame: 14±3 days
measure: General impression about the investigational device before use
timeFrame: 14±3 days
measure: Investigational device wearing comfort
timeFrame: 14±3 days
measure: Investigational device flexibility
timeFrame: 14±3 days
measure: Investigational device discretion
timeFrame: 14±3 days
measure: Ease of base plate handling
timeFrame: 14±3 days
measure: Investigational device adhesivity during wear time
timeFrame: 14±3 days
measure: Investigational device filter performance with deployed bag
timeFrame: 14±3 days
measure: Investigational device filter performance with undeployed bag
timeFrame: 14±3 days
measure: Efficacy of Investigational device gas release button
timeFrame: 14±3 days
measure: Noise during Investigational device wear time
timeFrame: 14±3 days
measure: Overall satisfaction questionnaire of the collection volume of the bag of the Investigational device
timeFrame: 14±3 days
measure: Overall security feeling questionnaire with the Investigational device
timeFrame: 14±3 days
measure: Overall satisfaction questionnaire with the Investigational device
timeFrame: 14±3 days
measure: Overall satisfaction questionnaire regarding bag deployment of the Investigational device
timeFrame: 14±3 days
measure: Overall satisfaction questionnaire with cap cover of the Investigational device
timeFrame: 14±3 days
measure: General impression about body image during use of the investigational product
timeFrame: 14±3 days
measure: Assessment questionnaire of willingness to use and the frequency of use in the future
timeFrame: 14±3 days
measure: Assessment of the investigational device wear time
timeFrame: 14±3 days
measure: Assessment questionnaire preference between the investigational device and usual appliance
timeFrame: 14±3 days
measure: Assessment of use of accessories
timeFrame: At each bag change during 14±3 days
measure: Assessment of the quality of life with Stoma-QoL questionnaire
timeFrame: At baseline, at 5±3 days and 14±3 days
measure: Number of participants with Adverse Event as a measure of safety and tolerability
timeFrame: At baseline, at 5±3 days and 14±3 days
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges François Leclerc
Study officials:
affiliation: University Hospital of Paris - Cochin
name: Mahaut LECONTE, MD
role: PRINCIPAL_INVESTIGATOR
References: