Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags
1 other identifier
interventional
20
1 country
1
Brief Summary
The aim of the current clinical investigation is to evaluate a new filter
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedFirst Posted
Study publicly available on registry
January 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
December 31, 2012
CompletedDecember 31, 2012
November 1, 2012
2 months
December 14, 2010
January 9, 2012
November 29, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Sensura
ACTIVE COMPARATORSenSura is the reference product and the product is already commercially available
Morfeus
EXPERIMENTALThe test product is the product with the proposed new filter (Morfeus)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
Study Sites (1)
Coloplast A/S
Humlebæk, 3050, Denmark
Results Point of Contact
- Title
- Director Medical Affairs
- Organization
- Coloplast A/S
Study Officials
- STUDY CHAIR
Daniel Carter, MSc
Coloplast A/S
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2010
First Posted
January 10, 2011
Study Start
January 1, 2011
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
December 31, 2012
Results First Posted
December 31, 2012
Record last verified: 2012-11