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
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Sponsor:
Torax Medical Incorporated
Information provided by (Responsible Party):
Torax Medical Incorporated
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Study Type | Interventional |
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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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | LINX System |
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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)
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Baseline Characteristics
Arm/Group Title | LINX System | |
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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 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 100 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
90 90.0%
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>=65 years |
10 10.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 100 participants | |
50.4 (12.4) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 100 participants | |
Female |
48 48.0%
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Male |
52 52.0%
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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 |
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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
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Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) total score
[1] Mean (Standard Deviation) Unit of measure: Total Score |
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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
The worst possible score is 50 based on a response of "5" to all 10 questions. |
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Use of daily proton-pump inhibitors (PPIs)
[1] Measure Type: Number Unit of measure: Participants |
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Number Analyzed | 100 participants | |
100 | ||
[1]
Measure Description: At time of enrollment, all medications used by a subject were documented.
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Years of proton-pump inhibitor use
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 100 participants | |
6.3 (4.8) |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
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):
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 |