Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags

Not Applicable

Completed

• Conditions: Ileostomy - Stoma
• Interventions: Device: SenSura; Device: Morfeus

• Registration Number: NCT01272869
• Lead Sponsor: Coloplast A/S

Brief Summary

The aim of the current clinical investigation is to evaluate a new filter

Detailed Description

The filter has been developed in order to significantly reduce problems with ballooning and other problems related to filter performance in people with a stoma.

Study Timeline

• Study First Submitted: 2010-12-14
• Study Start: 2011-01
• Study First Submitted QC: 2011-01-07
• Study First Posted: 2011-01-10
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2012-01-09
• Status Verified: 2012-11
• Results First Submitted QC: 2012-11-29
• Last Update Submitted: 2012-11-29
• Results First Posted: 2012-12-31
• Last Update Posted: 2012-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Be at least 18 years of age and have full legal capacity.
• Have given written informed consent.
• Be able to fill in the Case Report Form.
• Be ileostomy operated and have had a stoma for at least 6 months.
• Experience ballooning at least once per week.
• Be able to manage the bags themselves (application, removal).
• Be able to use a flat base plate.
• Have a stoma with a diameter less than 60 mm

Exclusion Criteria

• Persons who irrigate
• Currently suffer from peristomal skin problems (i.e. bleeding or broken skin).
• Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
• Pregnant or breastfeeding.
• Participate in other test at the same time.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sensura	SenSura	SenSura is the reference product and the product is already commercially available
Morfeus	Morfeus	The test product is the product with the proposed new filter (Morfeus)

Primary Outcome Measures

Name	Time	Method
Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period.	Daily or at every change of bag in a period of a maximum of 28 days	Data will not be recorded at specific time points due to individual changing patterns (1-2 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period.

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebaek, Denmark