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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UNKNOWN
2500 participants
OBSERVATIONAL
2016-05-31
2025-05-31
Brief Summary
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Detailed Description
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The main objectives are to collect data from everyday clinical practices and track patients from preoperative assessments to 5 years post surgical intervention to evaluate symptoms, medication use and side effects.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Laparoscopic Fundoplication Group
This group of patients are surgical candidates based on preoperative testing results for laparoscopic fundoplication antireflux procedure and possible hiatal hernia repair.
Laparoscopic Fundoplication
The gastric fundus of the stomach is wrapped or plicated around the lower end of the esophagus and and stitched in place reinforcing the closing function of the lower esophageal sphincter. The hiatus is also narrowed down with sutures or mesh to prevent or treat a concurrent hiatal hernia.
LINX Antireflux Device Group
This group of patients are surgical candidates based on preoperative testing results for the laparoscopic LINX antireflux device placement and possible hiatal hernia repair.
LINX Antireflux
The LINX is a flexible band of interlocked titanium beads with a magnetic core. The LINX is placed around the lower esophageal sphincter to help restore the function of the LES by preventing reflux into the esophagus.
Interventions
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Laparoscopic Fundoplication
The gastric fundus of the stomach is wrapped or plicated around the lower end of the esophagus and and stitched in place reinforcing the closing function of the lower esophageal sphincter. The hiatus is also narrowed down with sutures or mesh to prevent or treat a concurrent hiatal hernia.
LINX Antireflux
The LINX is a flexible band of interlocked titanium beads with a magnetic core. The LINX is placed around the lower esophageal sphincter to help restore the function of the LES by preventing reflux into the esophagus.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is a suitable surgical candidate, i.e. is able to undergo appropriate anesthesia and endoscopic procedure or laparoscopic surgery.
* Appropriate indications for and documentation of disease process requiring surgery. (Documented gastroesophageal reflux disease by accepted endoscopic or ambulatory reflux monitoring criteria, or have a hiatal hernia that meets accepted criteria for repair (e.g. large paraesophageal hernia with chest pain)).
* Subject is willing and able to cooperate with follow-up examinations
* Subject has been informed of the study procedures and treatment and has signed an informed consent for the study.
Exclusion Criteria
* Cannot understand trial requirements or is unable to comply with follow-up schedule
* Pregnant or nursing, or plans to become pregnant during the course of the study
* Medical illness (i.e. congestive heart failure) that may cause the subject to be non-compliant with or able to meet the protocol requirements or is associated with limited life expectancy (i.e. less than 3 years)
* Diagnosed psychiatric disorder (e.g. bipolar, schizophrenia, etc.), subjects that exhibit depression that are on appropriate medication(s) are allowable.
21 Years
ALL
No
Sponsors
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The Heartburn Foundation
OTHER
Responsible Party
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Principal Investigators
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Reginald Bell, MD
Role: PRINCIPAL_INVESTIGATOR
The Heartburn Foundation
Locations
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Advanced Surgeons, PC
Birmingham, Alabama, United States
University of Southern Alabama
Mobile, Alabama, United States
The Arkansas Heartburn Treatment Center
Heber Springs, Arkansas, United States
Bass Medical Group
Walnut Creek, California, United States
HealthOne Cardiothoracic Surgery Associates
Aurora, Colorado, United States
Institute of Esophageal and Reflux Surgery
Englewood, Colorado, United States
Suncoast Surgical Associates
Brandon, Florida, United States
South Florida Surgical Specialists, LLC
Coral Springs, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Tampa Bay Reflux Center
Riverview, Florida, United States
The Tampa Bay Reflux Center
Tampa, Florida, United States
Coastal Carolina Bariatric and Surgical Center
Summerville, South Carolina, United States
Baylor Scott and White Research Institute
Dallas, Texas, United States
Baylor University Medical Center at Dallas
Dallas, Texas, United States
Houston Methodist Research Institute
Houston, Texas, United States
North Texas Surgical Oncology Associates
Plano, Texas, United States
Swedish Health Services
Seattle, Washington, United States
Affinity Medical Group
Chilton, Wisconsin, United States
Froedtert & The Medical College of Wisconsin Hospitals and Health Partners
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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THF001
Identifier Type: -
Identifier Source: org_study_id
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