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

Gastroesophageal Reflux Disease (GERD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940185
• Other study ID #: 3545
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)

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