Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags

Ileostomy - Stoma Clinical Trial

Official title:

Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272869
• Other study ID #: CP211OC
• Status: Completed
• Phase: N/A
• First received: December 14, 2010
• Last updated: November 29, 2012
• Start date: January 2011
• Est. completion date: March 2011

Study information

• Verified date: November 2012
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Ileostomy - Stoma

Intervention

Device:
• SenSura
The ostomy bag filter will be tested for a period of 14 days
• Morfeus
The new ostomy bag filter will be tested for a period of 14 days

Locations

Country	Name	City	State
Denmark	Coloplast A/S	Humlebaek

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period.	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.	Daily or at every change of bag in a period of a maximum of 28 days	No