A Post-Approval Study of the LINX® Reflux Management System
1 other identifier
observational
200
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2012
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2012
CompletedFirst Submitted
Initial submission to the registry
September 6, 2013
CompletedFirst Posted
Study publicly available on registry
September 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedJanuary 5, 2024
January 1, 2024
11 years
September 6, 2013
January 2, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Reduction of total GERD-HRQL score
Successful reduction of ≥ 50% in the total GERD-HRQL as compared to baseline.
6 months, 12 months, and annually to 60 months
Serious, device-related adverse events
Reporting all serious device-related adverse events and summarizing by the number of events, the number of study patients with event, and the percent of study patients implanted with event. No formal statistical hypothesis tests will be conducted.
60 months
Secondary Outcomes (3)
Related Adverse Events
120 months
pH Measurements
The secondary measurements will be evaluated at yearly interval to 120 months (esophageal pH not conducted at 72, 84, 96 and 108 months)
Reduction of Symptoms
The secondary measurements will be evaluated at yearly interval to 120 months
Study Arms (1)
LINX device
Patients implanted with the LINX® Reflux Management System.
Interventions
Eligibility Criteria
Patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Keck Medical Center of Univeristy of Southern California
Los Angeles, California, 90033, United States
University of California San Diego
San Diego, California, 92103, United States
Swedish Medical Center/SurgOne
Englewood, Colorado, 80110, United States
Albany Surgical
Albany, Georgia, 31701, United States
Esophageal Institute of Atlanta, PC.
Atlanta, Georgia, 30309, United States
Candler Hospital
Savannah, Georgia, 31406, United States
Bingham Memorial Hospital
Blackfoot, Idaho, 83221, United States
Beth Israel
Boston, Massachusetts, 02215, United States
Cuyuna Regional Medical Center
Crosby, Minnesota, 56441, United States
VIP Surg PLLC
Las Vegas, Nevada, 89113, United States
University Hospitals Cleveland Medical Center - Geauga
Cleveland, Ohio, 44106, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
The Oregon Clinic
Portland, Oregon, 97213, United States
Allegheny Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
Virginia Hospital Center
Arlington, Virginia, 22205, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Froedtert and Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Louie BE, Smith CD, Smith CC, Bell RCW, Gillian GK, Mandel JS, Perry KA, Birkenhagen WK, Taiganides PA, Dunst CM, McCollister HM, Lipham JC, Khaitan LK, Tsuda ST, Jobe BA, Kothari SN, Gould JC. Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study. Ann Surg. 2019 Aug;270(2):302-308. doi: 10.1097/SLA.0000000000002789.
PMID: 29697454RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2013
First Posted
September 12, 2013
Study Start
June 30, 2012
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
January 5, 2024
Record last verified: 2024-01