Spy II Clinical Registry

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00751998
First received: September 11, 2008
Last updated: February 4, 2013
Last verified: February 2013
Results First Received: March 16, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Biliary Tract Diseases
Intervention: Device: SpyGlass

  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
Between November 27, 2006 and April 4, 2008 a total of 297 subjects were enrolled.

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
Arm 1 Test of SpyGlass device

Participant Flow:   Overall Study
    Arm 1  
STARTED     297  
COMPLETED     277  
NOT COMPLETED     20  
Lost to Follow-up                 7  
Death                 11  
Withdrawal by Subject                 2  



  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
Arm 1 Test of SpyGlass device

Baseline Measures
    Arm 1  
Number of Participants  
[units: participants]
  297  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     157  
>=65 years     140  
Age  
[units: years]
Mean ± Standard Deviation
  62.9  ± 16.2  
Gender  
[units: participants]
 
Female     152  
Male     145  
Region of Enrollment  
[units: participants]
 
France     15  
United States     224  
Belgium     11  
Denmark     10  
Germany     26  
Italy     11  



  Outcome Measures

1.  Primary:   Procedural Success as Defined by: 1. Ability to Visualize Stricture & Obtain Biopsy of Lesion Adequate for Histological Examination in Suspected Malignancy Cases or 2. Ability to Visualize Stone(s) & Successfully Initiate Stone Fragmentation & Removal.   [ Time Frame: During Procedure ]

2.  Secondary:   Impact of SpyGlass DVS Cholangioscopy With or Without Biopsy on Diagnosis.   [ Time Frame: Procedural through end of study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Impact of SpyGlass DVS Cholangioscopy With or Without Biopsy on Subject Management.   [ Time Frame: Procedure or at 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Ability to Visualize and Access Various Targeted Anatomic Areas.   [ Time Frame: Procedure ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Sensitivity of SpyBite Biopsy Forceps in Malignant Strictures.   [ Time Frame: Post Procedure ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Safety   [ Time Frame: Procedural through end of study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

7.  Secondary:   Device Durability and Device Performance.   [ Time Frame: Procedure ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Health Resources Utilization (Health Economics)   [ Time Frame: Procedure through end of study. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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 text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Joyce Peetermans, PhD, Director Endoscopy Clinical
Organization: Boston Scientific Corporation
phone: 508-683-4211
e-mail: peetermj@bsci.com


No publications provided


Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00751998     History of Changes
Other Study ID Numbers: E7012
Study First Received: September 11, 2008
Results First Received: March 16, 2011
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board