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Coloplast DialogueStudy

This study has been completed.
Information provided by (Responsible Party):
Coloplast A/S Identifier:
First received: February 21, 2008
Last updated: February 9, 2012
Last verified: January 2012
Results First Received: October 6, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Stoma
Intervention: Device: SenSura

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
SenSura Test of SenSura for 6-8 weeks

Participant Flow:   Overall Study
STARTED   3017 
Quality of Life   2672 [1] 
Adverse Event                44 
Protocol Violation                33 
Withdrawal by Subject                10 
Physician Decision                9 
Product dysfunction                21 
other/unknown reason                104 
[1] Attended both visit 1 and visit 2

  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.
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Reporting Groups
SenSura Test of SenSura for 6-8 weeks

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 63.2  (14.3) 
Gender [1] 
[Units: Participants]
Female   1541 
Male   1474 
[1] Gender is unknown for 2 participants

  Outcome Measures

1.  Primary:   Quality of Life (Scale 0(Worst)-100(Best))   [ Time Frame: 6-8 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Helle Aaes Senior Scientific Manager
Organization: Coloplast
phone: +45 49112949

Responsible Party: Coloplast A/S Identifier: NCT00626821     History of Changes
Other Study ID Numbers: DK175OS
Study First Received: February 21, 2008
Results First Received: October 6, 2011
Last Updated: February 9, 2012