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Accuracy of Spybite Forceps When Compared to Conventional Sampling Methods

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01227382
First Posted: October 25, 2010
Last Update Posted: August 3, 2015
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: June 29, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Conditions: Accuracy of Tissue Diagnosis
Bile Duct Stricture
Pancreatic Duct Stricture
Intervention: Procedure: ERCP with cholangiopancreatoscopy

  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
  Description
Indeterminate Biliary Lesions Requiring Tissue Sampling Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.

Participant Flow:   Overall Study
    Indeterminate Biliary Lesions Requiring Tissue Sampling
STARTED   26 
COMPLETED   26 
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.
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Reporting Groups
  Description
Indeterminate Biliary Lesions Requiring Tissue Sampling Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.

Baseline Measures
   Indeterminate Biliary Lesions Requiring Tissue Sampling 
Overall Participants Analyzed 
[Units: Participants]
 26 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.92  (13.37) 
Gender 
[Units: Participants]
 
Female   11 
Male   15 
Region of Enrollment 
[Units: Participants]
 
United States   26 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Accurate Diagnoses of Cancer   [ Time Frame: up to 7 days after the procedure ]

2.  Secondary:   Procedure Technical Success   [ Time Frame: day 1 ]

3.  Secondary:   Total Procedure Time   [ Time Frame: 120 minutes ]

4.  Secondary:   Total Cholangioscopy Time   [ Time Frame: 60 minutes ]

5.  Secondary:   Cholangioscopy Visualization Time   [ Time Frame: 30 minutes ]

6.  Secondary:   Sampling Times for Each Device   [ Time Frame: 15 minutes ]

7.  Secondary:   Adverse Events   [ Time Frame: 24 hours ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Peter V. Draganov
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: NCT01227382     History of Changes
Other Study ID Numbers: SpyBite
First Submitted: October 18, 2010
First Posted: October 25, 2010
Results First Submitted: June 29, 2015
Results First Posted: August 3, 2015
Last Update Posted: August 3, 2015