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OpenTrials
Completed

NCT Number: NCT01940185

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

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.

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Key information

Conditions

Gastroesophageal Reflux Disease (GERD) Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Keck Medical Center of Univeristy of Southern California, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LINX device

Device

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Torax Medical Incorporated

Industry

Registry information

Important dates

Study start
2012
Primary completion
2023
Study completion
2023
First posted
Sep 12, 2013
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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