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Trial record 18 of 226 for:    "Barrett syndrome"

HALO Patient Registry: Ablation of Barrett's Esophagus

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ClinicalTrials.gov Identifier: NCT00848237
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : February 5, 2016
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Barrett Esophagus
Intervention: Device: Radiofrequency Ablation (HALO Ablation Systems)

  Participant Flow

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
Treatment

All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.

Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy.


Participant Flow:   Overall Study
    Treatment
STARTED   5521 
COMPLETED   4982 
NOT COMPLETED   539 



  Baseline Characteristics

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
Treatment

All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.

Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy.


Baseline Measures
   Treatment 
Overall Participants Analyzed 
[Units: Participants]
 5521 
Age [1] 
[Units: Participants]
 
<=18 years   1 
Between 18 and 65 years   3235 
>=65 years   2279 
[1] Note: 6 subjects: Age unknown
Age 
[Units: Years]
Mean (Standard Deviation)
 61.6  (11.4) 
Gender 
[Units: Participants]
 
Female   1469 
Male   4052 
Region of Enrollment 
[Units: Participants]
 
United States   5521 


  Outcome Measures

1.  Primary:   Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up   [ Time Frame: 1 year ]

2.  Primary:   Histological Clearance Rate for Intestinal Metaplasia (CE-IM)   [ Time Frame: 1 year ]

3.  Primary:   Histological Clearance Rate for Dysplasia (CE-D)   [ Time Frame: 1 year ]

4.  Primary:   Percentage of Patients With Sub-squamous Intestinal Metaplasia at 1 Year Follow up   [ Time Frame: 1 year ]

5.  Primary:   Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month   [ Time Frame: 12 month ]

6.  Primary:   Adverse Event Incidence   [ Time Frame: 12 month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
Endoscopic clearance rate for Barrett's esophagus-Percentage of patients with no endoscopically visible Barrett's esophagus at 1 year follow-up: This endpoint is a visual and not reliable or accurate.


  More Information

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:

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT00848237     History of Changes
Other Study ID Numbers: B-500
First Submitted: December 20, 2007
First Posted: February 20, 2009
Results First Submitted: September 11, 2015
Results First Posted: February 5, 2016
Last Update Posted: February 5, 2016