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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01940185
Other study ID # 3545
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 30, 2012
Est. completion date June 30, 2023

Study information

Verified date January 2024
Source Torax Medical Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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.

Study Design


Intervention

Device:
LINX device


Locations

Country Name City State
United States Albany Surgical Albany Georgia
United States Virginia Hospital Center Arlington Virginia
United States Esophageal Institute of Atlanta, PC. Atlanta Georgia
United States Bingham Memorial Hospital Blackfoot Idaho
United States Beth Israel Boston Massachusetts
United States University Hospitals Cleveland Medical Center - Geauga Cleveland Ohio
United States Ohio State University Wexner Medical Center Columbus Ohio
United States Cuyuna Regional Medical Center Crosby Minnesota
United States Swedish Medical Center/SurgOne Englewood Colorado
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States VIP Surg PLLC Las Vegas Nevada
United States Keck Medical Center of Univeristy of Southern California Los Angeles California
United States Froedtert and Medical College of Wisconsin Milwaukee Wisconsin
United States Knox Community Hospital Mount Vernon Ohio
United States Allegheny Western Pennsylvania Hospital Pittsburgh Pennsylvania
United States The Oregon Clinic Portland Oregon
United States University of California San Diego San Diego California
United States Candler Hospital Savannah Georgia
United States Swedish Medical Center Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Torax Medical Incorporated

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Related Adverse Events Incidence rate of of device- and/or procedure-related adverse events 120 months
Secondary pH Measurements Reduction from baseline in Total % time esophageal pH<4 The secondary measurements will be evaluated at yearly interval to 120 months (esophageal pH not conducted at 72, 84, 96 and 108 months)
Secondary Reduction of Symptoms 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. The secondary measurements will be evaluated at yearly interval to 120 months
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