A Post-Approval Study of the LINX® Reflux Management System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01940185|
Recruitment Status : Active, not recruiting
First Posted : September 12, 2013
Last Update Posted : June 13, 2019
|Condition or disease||Intervention/treatment|
|Gastroesophageal Reflux Disease (GERD)||Device: LINX device|
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Official Title:||A Post-Approval Study of the LINX® Reflux Management System|
|Actual Study Start Date :||June 30, 2012|
|Estimated Primary Completion Date :||October 31, 2020|
|Estimated Study Completion Date :||October 31, 2025|
Patients implanted with the LINX® Reflux Management System.
Device: LINX device
- Reduction of total GERD-HRQL score [ Time Frame: 6 months, 12 months, and annually to 60 months ]Successful reduction of ≥ 50% in the total GERD-HRQL as compared to baseline.
- Serious, device-related adverse events [ Time Frame: 60 months ]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.
- Related Adverse Events [ Time Frame: 120 months ]Incidence rate of of device- and/or procedure-related adverse events
- pH Measurements [ Time Frame: The secondary measurements will be evaluated at yearly interval to 120 months (esophageal pH not conducted at 72, 84, 96 and 108 months) ]Reduction from baseline in Total % time esophageal pH<4
- Reduction of Symptoms [ Time Frame: The secondary measurements will be evaluated at yearly interval to 120 months ]Reduction from baseline on Foregut Symptom Questionnaire (frequency and severity of heartburn and regurgitation, extra-esophageal symptoms and side effect profile). No formal statistical hypothesis tests will be conducted. Any statistical analyses will be primarily descriptive.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01940185