Clinical Investigation for New Filter to Ostomy Bags

Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags

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

Study Overview

• Status: Completed
• Conditions: Colostomy
• Intervention / Treatment: Device: SenSura; Device: Morfeus

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Humlebaek, Denmark, 3050
    • Coloplast A/S

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SenSura; The reference product is the CE marked and launched SenSura product which is commercially available	Device: SenSura; The CE marked ostomy bag filter will be tested for a period of 14 days
Experimental: Morfeus; The test product is the product with the proposed new Morfeus filter	Device: Morfeus; The new ostomy bag filter (called Morfeus) will be tested for a period of 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Coloplast A/S

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: December 14, 2010
• First Submitted That Met QC Criteria: January 7, 2011
• First Posted (Estimate): January 10, 2011

Study Record Updates

• Last Update Posted (Estimate): April 1, 2013
• Last Update Submitted That Met QC Criteria: February 22, 2013
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: CP210OC