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
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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
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.

Baseline Measures
    LINX System  
Number of Participants  
[units: participants]
  100  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     90  
>=65 years     10  
Age  
[units: years]
Mean ± Standard Deviation
  50.4  ± 12.4  
Gender  
[units: participants]
 
Female     48  
Male     52  
Region of Enrollment  
[units: participants]
 
United States     96  
Netherlands     4  
Total percentage of monitoring time esophageal pH <4 [1]
[units: percent of time pH<4]
Mean ± Standard Deviation
  11.6  ± 4.7  
Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) total score [2]
[units: Total Score]
Mean ± Standard Deviation
  26.6  ± 6.6  
Use of daily proton-pump inhibitors (PPIs) [3]
[units: participants]
  100  
Years of proton-pump inhibitor use  
[units: years]
Mean ± Standard Deviation
  6.3  ± 4.8  
[1] At baseline, all subjects were evaluated with esophageal pH monitoring with GERD medications discontinued for at least 7 days using the BRAVO System
[2]

The GERD-HRQL scale was administered at baseline with GERD medications discontinued for at least seven days. GERD-HRQL scale objectively quantifies symptom severity. The GERD-HRQL scale consists of 10 questions with the following Responses Scale:

0 = No Symptoms

  1. = Symptoms noticeable, but not bothersome
  2. = Symptoms noticeable and bothersome, but not every day
  3. = Symptoms bothersome every day
  4. = Symptoms affect daily activities
  5. = Symptoms are incapacitating, unable to do daily activities

The worst possible score is 50 based on a response of "5" to all 10 questions.

[3] At time of enrollment, all medications used by a subject were documented.



  Outcome Measures
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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 ]
  Hide Outcome Measure 3

Measure Type Secondary
Measure Title At Least a 50% Reduction in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Total Score Compared to Baseline
Measure Description No text entered.
Time Frame 12 months  
Safety Issue No  

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
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.

Measured Values
    LINX System  
Number of Participants Analyzed  
[units: participants]
  100  
At Least a 50% Reduction in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Total Score Compared to Baseline  
[units: participants]
  92  

No statistical analysis provided for At Least a 50% Reduction in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Total Score Compared to Baseline



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