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LINX Reflux Management System Clinical Study Protocol

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ClinicalTrials.gov Identifier: NCT00776997
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : November 13, 2013
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Torax Medical Incorporated

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gastroesophageal Reflux
Intervention Device: Magnetic Sphincter Augmentation
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LINX System
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 100
Completed 98 [1]
Not Completed 2
Reason Not Completed
Adverse Event             2
[1]
98 subjects evaluated at 12-months. Endpoint analysis based on all subjects treated (n=100)
Arm/Group Title LINX System
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
<=18 years
0
   0.0%
Between 18 and 65 years
90
  90.0%
>=65 years
10
  10.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
50.4  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
48
  48.0%
Male
52
  52.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 100 participants
United States 96
Netherlands 4
Percentage of total monitoring time esophageal pH <4   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of total monitoring time
Number Analyzed 100 participants
11.6  (4.7)
[1]
Measure Description: At baseline, all subjects were evaluated with esophageal pH monitoring with GERD medications discontinued for at least 7 days using the BRAVO System
Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Total Score
Number Analyzed 100 participants
26.6  (6.6)
[1]
Measure Description:

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.
Use of daily proton-pump inhibitors (PPIs)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants
100
[1]
Measure Description: At time of enrollment, all medications used by a subject were documented.
Years of proton-pump inhibitor use  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
6.3  (4.8)
1.Primary Outcome
Title Rate of Occurrence for Device and Procedure Related Serious Adverse Events (SAEs).
Hide Description

SAE was defined as any untoward medical occurrence, whether related to the study device or procedure or not, that meets one or more of the following criteria:

  • Results in death
  • Is life-threatening
  • Requires subject hospitalization > 24 hours
  • Requires prolongation of an existing hospitalization
  • Results in persistent or significant disability/incapacity
  • Results in fetal distress, fetal death, or a congenital anomaly or birth defect
  • Requires intervention to prevent permanent impairment or damage.

Outcome measure reports number of subjects with reported events.
Time Frame through 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LINX System
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: participants
6
2.Primary Outcome
Title 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.
Hide Description The analysis cohort for the primary efficacy analysis was the treated population which includes all implanted subjects and was determined through esophageal pH testing.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LINX System
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: participants
64
3.Secondary Outcome
Title At Least a 50% Reduction in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Total Score Compared to Baseline
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LINX System
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: participants
92
4.Secondary Outcome
Title Average Daily Proton-pump Inhibitor (PPI) Dosage Reduced by at Least 50% Compared to Baseline
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LINX System
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: participants
93
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LINX System
Hide Arm/Group Description 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.
All-Cause Mortality
LINX System
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
LINX System
Affected / at Risk (%) # Events
Total   6/100 (6.00%)    
Gastrointestinal disorders   
Dysphagia †  3/100 (3.00%)  3
Nausea †  2/100 (2.00%)  2
Odynophagia †  1/100 (1.00%)  1
Vomiting †  2/100 (2.00%)  2
General disorders   
Pain † [1]  1/100 (1.00%)  1
†
Indicates events were collected by systematic assessment
[1]
unknown causality
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LINX System
Affected / at Risk (%) # Events
Total   76/100 (76.00%)    
Gastrointestinal disorders   
Dysphagia †  68/100 (68.00%)  76
Stomach Bloating †  14/100 (14.00%)  15
Nausea †  7/100 (7.00%)  8
Odynophagia †  8/100 (8.00%)  8
Inability to belch or vomit †  6/100 (6.00%)  6
General disorders   
Pain †  24/100 (24.00%)  25
Hiccups †  8/100 (8.00%)  8
†
Indicates events were collected by systematic assessment
[Not Specified]
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Amy Derosier, VP of Clinical Affairs
Organization: Torax Medical
Phone: 651-361-8900
EMail: aderosier@toraxmedical.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Torax Medical Incorporated
ClinicalTrials.gov Identifier: NCT00776997    
Other Study ID Numbers: 1802
First Submitted: October 20, 2008
First Posted: October 22, 2008
Results First Submitted: April 25, 2012
Results First Posted: November 13, 2013
Last Update Posted: May 4, 2018