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

Colostomy Clinical Trial

Official title:

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

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
• 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

Related Conditions & MeSH terms

• Colostomy

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