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The Clinical Utility of Overtube Use at the Time of Endoscopy (Spirus)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00861263
First Posted: March 13, 2009
Last Update Posted: April 14, 2014
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.
Information provided by (Responsible Party):
University of Florida
Results First Submitted: November 12, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition: Small Bowel Visualization
Intervention: Device: overtube use during enteroscopy

  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
We started this study in June 2007 and ended this study in Oct 2012. We approached any patient who was scheduled in our endoscopy suite for an overtube enteroscopy.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The only significant event was that the subject was scheduled for an enteroscopy in our facility and a overtube was used at the time of endoscopy.

Reporting Groups
  Description
Enteroscopy Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study.

Participant Flow:   Overall Study
    Enteroscopy
STARTED   193 
COMPLETED   193 
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
Enteroscopy Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study.

Baseline Measures
   Enteroscopy 
Overall Participants Analyzed 
[Units: Participants]
 193 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   94 
>=65 years   99 
Age 
[Units: Years]
Mean (Standard Deviation)
 62  (10) 
Gender 
[Units: Participants]
 
Female   101 
Male   92 
Region of Enrollment 
[Units: Participants]
 
United States   193 


  Outcome Measures

1.  Primary:   Number of Patients With Persistent or Recurrent Bleeding   [ Time Frame: up to 6 yrs after after the endoscopy ]


  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 limitations were found


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


Results Point of Contact:  
Name/Title: Dr. Peter Draganov MD
Organization: University of FLorida
phone: 352-273-9472
e-mail: peter.draganov@medicine.ufl.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00861263     History of Changes
Other Study ID Numbers: Spirus Overtube
First Submitted: March 12, 2009
First Posted: March 13, 2009
Results First Submitted: November 12, 2013
Results First Posted: April 14, 2014
Last Update Posted: April 14, 2014