A Post-Approval Study of the LINX® Reflux Management System



Status:Active, not recruiting
Conditions:Gastroesophageal Reflux Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:21 - Any
Updated:1/31/2019
Start Date:June 2012
End Date:October 2025

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A Post-Approval Study of the LINX® Reflux Management System in a prospective, multicenter,
single-arm study, with patients as their own control to monitor the safety and efficacy of
the LINX implant procedure and device in a post-approval environment to supplement existing
safety and efficacy data.


Inclusion Criteria:

- Patient is a candidate for treatment with the LINX Reflux Management System

- Patient has provided written informed consent for participation in the post-approval
study.

- Patient has indicated a willingness to comply with study requirements and the
follow-up schedule and assessments.

- Patient has been diagnosed with GERD as defined by abnormal pH testing.

- Patient continues to have chronic GERD symptoms despite maximum medical therapy for
the treatment of reflux.

Exclusion Criteria:

- Patients with suspected or known allergies to titanium, stainless steel, nickel, or
ferrous materials.

- Known circumstances that would make it unlikely for the patient to complete follow-up
through 60 months.
We found this trial at
19
sites
Blackfoot, Idaho 83221
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Blackfoot, ID
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Albany, Georgia
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Albany, GA
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Arlington, Virginia 22205
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Arlington, VA
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Atlanta, Georgia 30309
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Atlanta, GA
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Boston, Massachusetts
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Boston, MA
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Cleveland, OH
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Columbus, OH
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Crosby, Minnesota 56441
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Crosby, MN
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Englewood, Colorado 80110
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Englewood, CO
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La Crosse, Wisconsin
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La Crosse, WI
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3530 East Flamingo Road
Las Vegas, Nevada 89121
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Las Vegas, NV
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from
Los Angeles, CA
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9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 805-3666
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
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Milwaukee, WI
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1330 Coshocton Ave
Mount Vernon, Ohio 43050
(740) 393-9000
Knox Community Hospital A community-owned, 115-bed, not-for-profit hospital located in Mount Vernon, Ohio (approximately 40...
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Mount Vernon, OH
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4800 Friendship Avenue
Pittsburgh, Pennsylvania 15224
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Pittsburgh, PA
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Portland, Oregon 97210
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from
Portland, OR
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San Diego, California 92093
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San Diego, CA
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Savannah, Georgia
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from
Savannah, GA
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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from
Seattle, WA
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