Clinical trial NCT01940185: A Post-Approval Study of the LINX® Reflux Management System
Official title: A Post-Approval Study of the LINX® Reflux Management System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease (GERD)
Lead sponsor: Torax Medical Incorporated
Sponsor class: INDUSTRY
First posted: 2013-09-12
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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.

Primary outcomes:
measure: Reduction of total GERD-HRQL score
timeFrame: 6 months, 12 months, and annually to 60 months
measure: Serious, device-related adverse events
timeFrame: 60 months
Secondary outcomes:
measure: Related Adverse Events
timeFrame: 120 months
measure: pH Measurements
timeFrame: The secondary measurements will be evaluated at yearly interval to 120 months (esophageal pH not conducted at 72, 84, 96 and 108 months)
measure: Reduction of Symptoms
timeFrame: The secondary measurements will be evaluated at yearly interval to 120 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Medical Center of Univeristy of Southern California
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Englewood
country: United States
facility: Swedish Medical Center/SurgOne
state: Colorado
city: Albany
country: United States
facility: Albany Surgical
state: Georgia
city: Atlanta
country: United States
facility: Esophageal Institute of Atlanta, PC.
state: Georgia
city: Savannah
country: United States
facility: Candler Hospital
state: Georgia
city: Blackfoot
country: United States
facility: Bingham Memorial Hospital
state: Idaho
city: Boston
country: United States
facility: Beth Israel
state: Massachusetts
city: Crosby
country: United States
facility: Cuyuna Regional Medical Center
state: Minnesota
city: Las Vegas
country: United States
facility: VIP Surg PLLC
state: Nevada
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center - Geauga
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Mount Vernon
country: United States
facility: Knox Community Hospital
state: Ohio
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny Western Pennsylvania Hospital
state: Pennsylvania
city: Arlington
country: United States
facility: Virginia Hospital Center
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert and Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
citation: 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 Augmentation: One Year Results From a Post Approval Study. Ann Surg. 2019 Aug;270(2):302-308. doi: 10.1097/SLA.0000000000002789.