Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01517178
Recruitment Status : Terminated
First Posted : January 25, 2012
Results First Posted : March 13, 2015
Last Update Posted : March 13, 2015
Information provided by (Responsible Party):
Coloplast A/S

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Leakage
Skin Condition
Interventions: Device: New ostomy base plate (SS)
Device: Standard Care base plate

  Participant Flow

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
A total of 33 subjects were enrolled in the trial. Of these, 6 discontinued during the New ostomy base plate run-in period prior to period 1 and were excluded from the Intention-To-Treat analysis set (no performance data obtained). 27 subjects comprised the intention-to-treat population.

Reporting Groups
Standard Care - New Ostomy Base Plate Subjects first test Standard Care then New ostomy base plate.
New Ostomy Base Plate - Standard Care Subjects first test New ostomy base plate then Standard Care.

Participant Flow for 2 periods

Period 1:   Period 1
    Standard Care - New Ostomy Base Plate   New Ostomy Base Plate - Standard Care
STARTED   16 [1]   11 
COMPLETED   12   6 
Adverse Event                1                2 
Lack of Efficacy                0                1 
E.g. study termination                3                1 
Withdrawal by Subject                0                1 
[1] One subject (who discontinued due to an adverse event) actually used New ostomy base plate.

Period 2:   Period 2
    Standard Care - New Ostomy Base Plate   New Ostomy Base Plate - Standard Care
STARTED   11 [1]   6 
COMPLETED   5   4 
Adverse Event                1                0 
Withdrawal by Subject                3                0 
E.g. study termination                2                2 
[1] One subject discontinued during run-in and did not start period 2.

  Baseline Characteristics

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
Intention-to-treat Analysis Set No text entered.

Baseline Measures
   Intention-to-treat Analysis Set 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 54.9  (12.8) 
[Units: Participants]
Female   14 
Male   13 
Region of Enrollment 
[Units: Participants]
France   6 
Denmark   19 
Iceland   1 
Germany   1 

  Outcome Measures

1.  Primary:   Degree of Output Under the Base Plate (Leakage).   [ Time Frame: Each test product was assessed for 2 weeks. ]

  Serious Adverse Events

  Other Adverse Events

  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
Early termination leading to small number of subjects analyzed.

  More Information

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: Tonny Karlsmark
Organization: Bispebjerg Hospital

Responsible Party: Coloplast A/S Identifier: NCT01517178     History of Changes
Other Study ID Numbers: CP215OC
First Submitted: June 24, 2011
First Posted: January 25, 2012
Results First Submitted: March 3, 2015
Results First Posted: March 13, 2015
Last Update Posted: March 13, 2015