Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Coloplast A/S

ClinicalTrials.gov Identifier:

NCT01272869

First received: December 14, 2010

Last updated: November 29, 2012

Last verified: November 2012

History of Changes

Purpose

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

Condition	Intervention
Ileostomy - Stoma	Device: SenSura Device: Morfeus


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags

Resource links provided by NLM:

MedlinePlus related topics: Ostomy

U.S. FDA Resources

Further study details as provided by Coloplast A/S:

Primary Outcome Measures:

Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period. [ Time Frame: Daily or at every change of bag in a period of a maximum of 28 days ] [ Designated as safety issue: No ]
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.


Enrollment:	20
Study Start Date:	January 2011
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Sensura SenSura is the reference product and the product is already commercially available	Device: SenSura The ostomy bag filter will be tested for a period of 14 days
Experimental: Morfeus The test product is the product with the proposed new filter (Morfeus)	Device: Morfeus The new ostomy bag filter will be tested for a period of 14 days

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272869

Locations


Denmark
Coloplast A/S
Humlebaek, Denmark, 3050

Sponsors and Collaborators

Coloplast A/S

Investigators


Study Chair:	Daniel Carter, MSc	Coloplast A/S

More Information


Responsible Party:	Coloplast A/S
ClinicalTrials.gov Identifier:	NCT01272869 History of Changes
Other Study ID Numbers:	CP211OC
Study First Received:	December 14, 2010
Results First Received:	January 9, 2012
Last Updated:	November 29, 2012
Health Authority:	Denmark: Danish Medicines Agency

ClinicalTrials.gov processed this record on September 26, 2016

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