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Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01303159
Recruitment Status : Terminated (EndoHPB probe is FDA approved and considered standard of care)
First Posted : February 24, 2011
Results First Posted : May 23, 2017
Last Update Posted : May 23, 2017
Sponsor:
Collaborator:
EMcision Limited
Information provided by (Responsible Party):
Michel Kahaleh, Weill Medical College of Cornell University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cholangiocarcinoma
Pancreatic Cancer
Intervention Device: Endoscopic bipolar radiofrequency probe (ENDOHPB)
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Radiofrequency Probe (ENDOHPB)
Hide Arm/Group Description

Intervention:

The EndoHPB Radiofrequency probe

Period Title: Overall Study
Started 29
Completed 6
Not Completed 23
Reason Not Completed
Death             16
Study Termination             7
Arm/Group Title Radiofrequency Probe (ENDOHPB)
Hide Arm/Group Description Intervention: The EndoHPB Radiofrequency probe
Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants
69  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
7
  24.1%
Male
22
  75.9%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 29 participants
29
 100.0%
1.Primary Outcome
Title Change From Baseline in Bile Duct Stricture Diameter
Hide Description To assess effectiveness of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants not analyzed has study was terminated before follow up data could be collected.
Arm/Group Title Radiofrequency Probe (ENDOHPB)
Hide Arm/Group Description:

Intervention:

The EndoHPB Radiofrequency probe

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description To assess safety of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Preliminary analyses because study was terminated before follow up data could be collected.
Arm/Group Title Radiofrequency Probe (ENDOHPB)
Hide Arm/Group Description:

Intervention:

The EndoHPB Radiofrequency probe

Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: participants
16
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Radiofrequency Probe (ENDOHPB)
Hide Arm/Group Description

Intervention:

The EndoHPB Radiofrequency probe

All-Cause Mortality
Radiofrequency Probe (ENDOHPB)
Affected / at Risk (%)
Total   16/29 (55.17%)    
Hide Serious Adverse Events
Radiofrequency Probe (ENDOHPB)
Affected / at Risk (%) # Events
Total   16/29 (55.17%)    
Gastrointestinal disorders   
Fever *  4/29 (13.79%)  4
Death *  16/29 (55.17%)  16
Gastrointestinal Bleeding *  1/29 (3.45%)  1
Cholecystitis *  1/29 (3.45%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Radiofrequency Probe (ENDOHPB)
Affected / at Risk (%) # Events
Total   0/29 (0.00%)    
Early study termination leading to no preliminary analyses. Total enrolled 29, only 6 subjects had follow up data of 6 months.
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
Layout table for Results Point of Contact information
Name/Title: Michel Kahaleh
Organization: Weill Cornell Medical College
Phone: 646-962-4797
EMail: mik9071@med.cornell.edu
Layout table for additonal information
Responsible Party: Michel Kahaleh, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01303159    
Other Study ID Numbers: 1107011793
First Submitted: February 18, 2011
First Posted: February 24, 2011
Results First Submitted: February 16, 2017
Results First Posted: May 23, 2017
Last Update Posted: May 23, 2017