LINX Reflux Management System Clinical Study Protocol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Torax Medical Incorporated
ClinicalTrials.gov Identifier:
NCT00776997
First received: October 20, 2008
Last updated: November 22, 2013
Last verified: November 2013
Results First Received: April 25, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gastroesophageal Reflux
Intervention: Device: Magnetic Sphincter Augmentation

  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
LINX System All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.

Participant Flow:   Overall Study
    LINX System  
STARTED     100  
COMPLETED     98 [1]
NOT COMPLETED     2  
Adverse Event                 2  
[1] 98 subjects evaluated at 12-months. Endpoint analysis based on all subjects treated (n=100)



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rate of Occurrence for Device and Procedure Related Serious Adverse Events (SAEs).   [ Time Frame: through 24 months ]

2.  Primary:   Normalization of Esophageal Acid Exposure Time or Reduced Total Acid Exposure Time of at Least 50% Compared to the Subject's Baseline Measurement by Esophageal pH Testing.   [ Time Frame: 12 Months ]

3.  Secondary:   At Least a 50% Reduction in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Total Score Compared to Baseline   [ Time Frame: 12 months ]

4.  Secondary:   Average Daily Proton-pump Inhibitor (PPI) Dosage Reduced by at Least 50% Compared to Baseline   [ Time Frame: 12 months ]


  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: Amy Derosier, VP of Clinical Affairs
Organization: Torax Medical
phone: 651-361-8900
e-mail: aderosier@toraxmedical.com


No publications provided by Torax Medical Incorporated

Publications automatically indexed to this study:

Responsible Party: Torax Medical Incorporated
ClinicalTrials.gov Identifier: NCT00776997     History of Changes
Other Study ID Numbers: 1802
Study First Received: October 20, 2008
Results First Received: April 25, 2012
Last Updated: November 22, 2013
Health Authority: United States: Food and Drug Administration