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Colonoscopy Endoguide in Specialist Practice

This study has been completed.
Sponsor:
Collaborators:
A foundation of th Danish Association of Medical Specialists
Surgical Clinic, Allerød, Denmark
Information provided by (Responsible Party):
Lene Hendel, The Specialist Doctors at Rolighedsvej
ClinicalTrials.gov Identifier:
NCT01055782
First received: January 24, 2010
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
Results First Received: March 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Colonoscopy
Pain
Intervention: Device: Endoguide

  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
With Endoguide Colonoscopy completed with endoguide
Without Endoguide Colonoscopy completed without endoguide

Participant Flow:   Overall Study
    With Endoguide     Without Endoguide  
STARTED     555     449  
COMPLETED     555     449  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
With Endoguide Colonoscopy completed with endoguide
Without Endoguide Colonoscopy completed without endoguide
Total Total of all reporting groups

Baseline Measures
    With Endoguide     Without Endoguide     Total  
Number of Participants  
[units: participants]
 		  555     449     1004  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     382     297     679  
>=65 years     173     152     325  
Age  
[units: years]
Mean ± Standard Deviation 		  56  ± 14     56  ± 15     56  ± 15  
Gender  
[units: participants]
 		     
Female     308     256     564  
Male     247     193     440  
Region of Enrollment  
[units: participants]
 		     
Denmark     555     449     1004  



  Outcome Measures
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1.  Primary:   Completed Colonoscopy   [ Time Frame: immediately after colonoscopy ]
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Measure Type Primary
Measure Title Completed Colonoscopy
Measure Description No text entered.
Time Frame immediately after colonoscopy  
Safety Issue No  

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.
Choosen by randomization.

Reporting Groups
  Description
With Endoguide - Success Rate Exams completed with endoguide. Success rate/completion.
Without Endoguide Exams completed without endoguide. Success rate/completion.

Measured Values
    With Endoguide - Success Rate     Without Endoguide  
Number of Participants Analyzed  
[units: participants]
 		  555     449  
Completed Colonoscopy  
[units: participants]
 		  555     449  

No statistical analysis provided for Completed Colonoscopy



2.  Secondary:   Perception of Pain   [ Time Frame: After endoscopy (within 10mins) and 1 day after endoscopy ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  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
Early termination due to higher than expected eligible patients  


Results Point of Contact:  
Name/Title: Lene Hendel MD
Organization: Specialist Doctors Rolighedsvej
phone: +4545819090
e-mail: lene@hendel.dk


No publications provided


Responsible Party: Lene Hendel, The Specialist Doctors at Rolighedsvej
ClinicalTrials.gov Identifier: NCT01055782     History of Changes
Other Study ID Numbers: H-1-2009-80
Study First Received: January 24, 2010
Results First Received: March 23, 2012
Last Updated: June 6, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics