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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02602236
Other study ID # OPM-G-H-1401
Secondary ID 2015-A00611-48
Status Terminated
Phase N/A
First received November 4, 2015
Last updated February 3, 2017
Start date November 2015
Est. completion date October 2016

Study information

Verified date February 2017
Source BBraun Medical SAS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Terminated
Enrollment 31
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
AOS-C2000-B
1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day

Locations

Country Name City State
France Centre Georges François Leclerc Dijon

Sponsors (1)

Lead Sponsor Collaborator
BBraun Medical SAS

Country where clinical trial is conducted

France, 

Outcome

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