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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
Sponsor:
Information provided by (Responsible Party):
Torax Medical Incorporated

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.

Condition or disease Intervention/treatment
Gastroesophageal Reflux Disease (GERD) Device: LINX device

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Group/Cohort Intervention/treatment
LINX device
Patients implanted with the LINX® Reflux Management System.
Device: LINX device



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Related Adverse Events [ Time Frame: 120 months ]
    Incidence rate of of device- and/or procedure-related adverse events

  2. 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

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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.

Information from the National Library of Medicine

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


Locations
Show Show 19 study locations
Sponsors and Collaborators
Torax Medical Incorporated

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Responsible Party: Torax Medical Incorporated
ClinicalTrials.gov Identifier: NCT01940185    
Other Study ID Numbers: 3545
First Posted: September 12, 2013    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases