Ablation of Intestinal Metaplasia Containing Dysplasia

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Medtronic - MITG
ClinicalTrials.gov Identifier:
NCT00282672
First received: January 25, 2006
Last updated: December 28, 2015
Last verified: December 2015
Results First Received: September 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Barrett Esophagus
Interventions: Device: Ablation System plus anti-secretory medication
Device: Sham procedure plus anti-secretory medication

  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
No text entered.

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
LGD Sham Procedure First Then LGD Radiofrequency Ablation After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
LGD Radiofrequency Ablation No text entered.
HGD Sham Procedure First Then HGD Radiofrequency Ablation After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
HGD Radiofrequency Ablation No text entered.

Participant Flow for 3 periods

Period 1:   1 Year
    LGD Sham Procedure First Then LGD Radiofrequency Ablation     LGD Radiofrequency Ablation     HGD Sham Procedure First Then HGD Radiofrequency Ablation     HGD Radiofrequency Ablation  
STARTED     22     42     21     42  
COMPLETED     19     40     20     38  
NOT COMPLETED     3     2     1     4  

Period 2:   2 Year: Sham Crossed Over to RFA
    LGD Sham Procedure First Then LGD Radiofrequency Ablation     LGD Radiofrequency Ablation     HGD Sham Procedure First Then HGD Radiofrequency Ablation     HGD Radiofrequency Ablation  
STARTED     19 [1]   40     16 [2]   38  
COMPLETED     16     39     15     36  
NOT COMPLETED     3     1     1     2  
[1] 19 crossed over to RFA treatment
[2] 16 Crossed over to RFA treatment

Period 3:   5 Year: Follow up
    LGD Sham Procedure First Then LGD Radiofrequency Ablation     LGD Radiofrequency Ablation     HGD Sham Procedure First Then HGD Radiofrequency Ablation     HGD Radiofrequency Ablation  
STARTED     15 [1]   32 [2]   12 [3]   25 [4]
COMPLETED     14     27     12     20  
NOT COMPLETED     1     5     0     5  
[1] 1 withdrew
[2] 7 withdrew
[3] 3 withdrew
[4] 11 withdrew



  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
LGD Sham Procedure First Then LGD Radiofrequency Ablation After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
LGD Radiofrequency Ablation No text entered.
HGD Sham Procedure First Then LGD Radiofrequency Ablation After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
HGD Radiofrequency Ablation No text entered.
Total Total of all reporting groups

Baseline Measures
    LGD Sham Procedure First Then LGD Radiofrequency Ablation     LGD Radiofrequency Ablation     HGD Sham Procedure First Then LGD Radiofrequency Ablation     HGD Radiofrequency Ablation     Total  
Number of Participants  
[units: participants]
  22     42     21     42     127  
Age  
[units: years]
Mean (Standard Deviation)
  64.6  (1.9)     66.3  (1.4)     67.3  (1.8)     65.9  (1.4)     65.95  (8.95)  
Gender  
[units: participants]
         
Female     3     9     0     5     17  
Male     19     33     21     37     110  
Region of Enrollment  
[units: participants]
         
United States     22     42     21     42     127  



  Outcome Measures
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1.  Primary:   The % of Patients With Complete Eradication of Intestinal Metaplasia (IM) at 12 Month   [ Time Frame: 12 month ]

2.  Primary:   The % of Patients With Complete Eradication of Dysplasia at 12 Month   [ Time Frame: 12 month ]

3.  Primary:   The % of Patients With Complete Histological Clearance of Intestinal Metaplasia at 24 Months.   [ Time Frame: 24 Month ]

4.  Primary:   5 Year Extension: % of All Patients Enrolled in the Extension Protocol and Available for Analysis Demonstrating CR-IM at 5 Years   [ Time Frame: 5 years ]

5.  Primary:   Durability of Eradication With no Additional Treatments   [ Time Frame: 5 year ]

6.  Primary:   5 Year Extension: % of All Patients Enrolled in the Extension Protocol and Available for Analysis Demonstrating CR-D at 5 Years   [ Time Frame: 5 years ]

7.  Secondary:   The % of Patients With Complete Histological Clearance of IM at 12 Months, Comparing Treatment Versus Sham Control Groups Within a Specific Dysplasia Subgroup   [ Time Frame: 12 months ]

8.  Secondary:   Within the HGD Subgroup, the % of Patients With Complete Histological Clearance of HGD (CR-D) at 12 Months, Comparing Treatment Versus Sham Control Groups.   [ Time Frame: 12 Month ]

9.  Secondary:   Histological Clearance of IM (% Biopsies)   [ Time Frame: 12 months ]

10.  Secondary:   Progression of Dysplasia (i.e., HGD to Adenocarcinoma, or LGD to HGD or Adenocarcinoma)   [ Time Frame: 5 year ]

11.  Secondary:   Subject Discomfort : Chest Pain Score on Day 1   [ Time Frame: Day 1 , if ablated ]

12.  Secondary:   Quality of Life Questionnaire (Baseline v. 12 and 24 Mos)   [ Time Frame: 0, 12, and 24 months ]

13.  Secondary:   For 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension and Available for Analysis at 5 Years Demonstrating Any Adenocarcinoma in Any Biopsy Obtained From the Esophageal Body Since Primary RFA (0-5 Years)   [ Time Frame: 5 years ]

14.  Secondary:   5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension and Available for Analysis at 5 Years Demonstrating Any Adenocarcinoma in Any Biopsy Obtained From the Esophageal Body After 2 Years and Inclusive of the 5 Year Visit   [ Time Frame: 5 years ]

15.  Secondary:   5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 5 Year   [ Time Frame: 5 years ]

16.  Secondary:   5 Year Extension:Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-D at 5 Year   [ Time Frame: 5 years ]

17.  Secondary:   5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 4 Year   [ Time Frame: 4 years ]

18.  Secondary:   5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 3 Year   [ Time Frame: 3 years ]

19.  Secondary:   5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-D at 4 Year   [ Time Frame: 4 years ]

20.  Secondary:   5 Year Extension: Serious Adverse Event Incidence   [ Time Frame: 5 years ]

21.  Secondary:   5 Year Extension: All Cause Mortality of the Group From 2 to 5 Years.   [ Time Frame: 5 years ]

22.  Secondary:   Adverse Event Incidence   [ Time Frame: 12 months for Treatment and Sham Comparison ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Nicholas Shaheen
Organization: University of north Carolina
phone: (919) 966-7047
e-mail: nshaheen@med.unc.edu


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

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT00282672     History of Changes
Other Study ID Numbers: B-204
Study First Received: January 25, 2006
Results First Received: September 11, 2015
Last Updated: December 28, 2015
Health Authority: United States: Institutional Review Board