Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
500 participants
OBSERVATIONAL
2020-07-08
2032-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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LINX Reflux Management System
The LINX Reflux Management System consists of a series of titanium beads each with a magnetic core connected with independent titanium wires to form an annular shape when implanted. The attractive force of the magnetic beads is designed to provide additional strength to keep a weak lower esophageal sphincter (LES) closed. During swallowing, the magnetic beads slide away from each other on the independent titanium wire "links" to allow esophageal distention as the bolus passes by.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject with prospective plans for a LINX procedure
3. Subject provides written informed consent
4. Subject must be willing and able to complete questionnaires/ surveys electronically (ePROs)
Exclusion Criteria
2. Any reason which the Principal Investigator believes may cause the subject to be non-compliant with or unable to meet the protocol requirements (i.e. medical illness and/or limited life expectancy of less than 10 years)
Note: Physicians should refer to the LINX Reflux Management System IFU for a complete list of contraindications, warnings, and precautions.
21 Years
99 Years
ALL
No
Sponsors
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Ethicon Endo-Surgery
INDUSTRY
Responsible Party
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Principal Investigators
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Jörg Tomaszewski, MD
Role: STUDY_DIRECTOR
Ethicon Endo-Surgery
Locations
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University of South Alabama
Mobile, Alabama, United States
NW Allied Bariatric and Foregut Surgery
Tucson, Arizona, United States
Keck Hospital of USC
Los Angeles, California, United States
Institute of Esophageal and Reflux Surgery
Englewood, Colorado, United States
University of Southern Florida (Tampa General Hospital)
Tampa, Florida, United States
OSF Medical Group
Peoria, Illinois, United States
Saint Elizabeth Healthcare Edgewood
Edgewood, Kentucky, United States
Sparrow Hospital / Sparrow Medical Group
Lansing, Michigan, United States
East Carolina University / Vidant Medical Center
Greenville, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Gen Surg Assoc / Fairfield Medical Center
Lancaster, Ohio, United States
Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States
Minimal Access Surgery/Prisma Health - Upstate
Greenville, South Carolina, United States
Adv Surg Assoc / Self Regional Healthcare
Greenwood, South Carolina, United States
Lexington Surgery
West Columbia, South Carolina, United States
Panhandle Weight Loss Center
Amarillo, Texas, United States
Houston Methodist
Houston, Texas, United States
Bariatric Medical Institute of Texas
San Antonio, Texas, United States
Richmond Surg / Henrico Doctors' Hospital
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Fox Valley Surgical Associates
Appleton, Wisconsin, United States
MedUni Wien / Universitatsklinik fur Chirurgie
Vienna, , Austria
Marien Hospital Herne
Herne, , Germany
Univ of Milano / IRCCS Policlinico San Donato
San Donato Milanese, , Italy
National University Hospital
Singapore, , Singapore
Epsom Hospital
Epsom, , United Kingdom
Guy's and St. Thomas' Hospitals
London, , United Kingdom
RefluxUK
Royal Tunbridge Wells, , United Kingdom
Countries
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Other Identifiers
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TRX_2018_01
Identifier Type: -
Identifier Source: org_study_id