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
Results First Received: January 9, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Ileostomy - Stoma
Interventions: Device: SenSura
Device: Morfeus

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The subjects were recruited from a user data base in Denmark.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
20 subjects were enrolled and randomized in the study.

Reporting Groups
  Description
Sensura First; Then Morfeus The reference product is the SenSura product which is already commercially available
Morfeus First; Then Sensura The test product with the Morfeus filter is the test product with the proposed new filter.

Participant Flow for 2 periods

Period 1:   Period 1 (14 Days)
    Sensura First; Then Morfeus     Morfeus First; Then Sensura  
STARTED     10     10  
COMPLETED     10     10  
NOT COMPLETED     0     0  

Period 2:   Period 2 (14 Days)
    Sensura First; Then Morfeus     Morfeus First; Then Sensura  
STARTED     10     10  
COMPLETED     9     10  
NOT COMPLETED     1     0  
Adverse Event                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sensura The reference product is the SenSura product which is already commercially available
Morfeus The test product is the product with the proposed new filter (Morfeus)
Total Total of all reporting groups

Baseline Measures
    Sensura     Morfeus     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: years]
Mean ± Standard Deviation
  59  ± 13     61  ± 10     60  ± 11  
Gender  
[units: participants]
     
Female     6     1     7  
Male     4     9     13  



  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Director Medical Affairs
Organization: Coloplast A/S
phone: 4549111111
e-mail: dkbir@coloplast.com


No publications provided


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