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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01273038
Other study ID # CP210OC
Secondary ID
Status Completed
Phase N/A
First received December 14, 2010
Last updated February 22, 2013
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 new 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 colostomy 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


Intervention

Device:
Morfeus
The new ostomy bag filter (called Morfeus) will be tested for a period of 14 days
SenSura
The CE marked 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 SenSura Test Period. Data will not be recorded at specific time points due to individual changing patterns (1-3 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
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