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Endoscopic Therapy of Malignant Bile Duct Strictures

This study has been terminated.
(Lack of enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01543607
First Posted: March 5, 2012
Last Update Posted: April 24, 2017
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):
William R. Brugge, MD, Massachusetts General Hospital
Results First Submitted: March 13, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Obstruction of Biliary Tree
Biliary Tract Cancer
Biliary Tract Neoplasms
Intervention: Device: Radiofrequency ablation catheter (Habib EndoHBP)

  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
Treatment

Radiofrequency ablation catheter

Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct


Participant Flow:   Overall Study
    Treatment
STARTED   1 
COMPLETED   1 
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
Treatment

Radiofrequency ablation catheter

Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct


Baseline Measures
   Treatment 
Overall Participants Analyzed 
[Units: Participants]
 1 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      1 100.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Safety: Number of Bile Leak After RFA Procedure   [ Time Frame: 2 years ]

2.  Secondary:   Feasibility: Ease of the Radiofrequency Ablation Catheter Placement   [ Time Frame: 2 years ]

3.  Secondary:   Effectiveness: Change From Baseline in Bile Duct Diameter.   [ Time Frame: 2 years ]


  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: William R. Brugge
Organization: Mass. General Hospital
phone: 617-724-0578
e-mail: wbrugge@partners.org



Responsible Party: William R. Brugge, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01543607     History of Changes
Other Study ID Numbers: 11-405
First Submitted: February 15, 2012
First Posted: March 5, 2012
Results First Submitted: March 13, 2017
Results First Posted: April 24, 2017
Last Update Posted: April 24, 2017