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