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A Feasibility Study of a Fecal Incontinence Management System for Medical Use

This study has been terminated.
(Due to numerous delays in study start-up process...)
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT00556972
First received: November 9, 2007
Last updated: November 29, 2012
Last verified: November 2012
Results First Received: August 2, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Fecal Incontinence
Intervention: Device: Fecal Incontinence Management System

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Fecal Incontinence Management System The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.

Participant Flow:   Overall Study
    Fecal Incontinence Management System  
STARTED     4  
COMPLETED     4  
NOT COMPLETED     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
Fecal Incontinence Management System The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.

Baseline Measures
    Fecal Incontinence Management System  
Number of Participants  
[units: participants]
  4  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     2  
>=65 years     2  
Age  
[units: years]
Mean ± Standard Deviation
  62.0  ± 14.2  
Gender  
[units: participants]
 
Female     3  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     4  



  Outcome Measures
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1.  Primary:   The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed)   [ Time Frame: 5 days ]

2.  Secondary:   Is the Barrier Size and Shape Satisfactory   [ Time Frame: Subjects were followed for the duration of the study, an average of 23 hours ]

3.  Secondary:   Assessment of Skin 0-2 Inches From the Edge of the Anus   [ Time Frame: Subjects were evaluated before and after test ]

4.  Secondary:   What is Your Assessment of the Ease of Correct Application of the Anal Adhesive?   [ Time Frame: After application of product ]


  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
No overall conclusions could be drawn, due to the limited amount of data (N=4 due to delays and low recruitment rate). A new study, with a higher sample size needs to be executed, if the objectives set in this study are to be investigated thoroughly.


  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: Thais Benjamin N. Christensen, Senior Clinical Project Manager
Organization: Coloplast A/S
phone: +4549112668
e-mail: dkthc@coloplast.com


No publications provided


Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00556972     History of Changes
Other Study ID Numbers: DK172OS
Study First Received: November 9, 2007
Results First Received: August 2, 2011
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board