LINX Reflux Management System or Fundoplication Clinical Study in Patients With Hiatal Hernia >3 cm

Stopped early

Conditions studied: Hiatal Hernia Large, Gastro Esophageal Reflux, Hiatal Hernia, Hiatal Hernia, Paraesophageal, Reflux, Gastroesophageal, Reflux Acid

In brief

The cohort registry is both retrospective and prospective, multicenter surveillance of subjects who underwent a prior hiatal hernia repair and Magnetic Sphincter Augmentation or fundoplication construction more than 2 years prior to initial study visit.

Key facts

Study ID

NCT04695171

Run by

Foregut Research Foundation

People needed

336

Starts

2021-01-14

Expected to finish

2026-01-14

Last updated by the study team

2026-02-09

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must be at least 21 years of age and at least the minimum Age of Majority according to applicable state law.
• Underwent primary index procedure of laparoscopic repair of a hiatal hernia larger than 3 cm with placement of a LINX® device or construction of a fundoplication for reflux control more than 2 years prior to his/her enrollment or has completed 1 or 2 of the barium swallows and GERD-HRQLs within study time points with or without hiatal hernia recurrence.
• 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.

You may not qualify if…

• The surgical procedure was completed as an emergency procedure
• Currently being treated with another investigational drug or investigational device
• Suspected or confirmed esophageal or gastric cancer
• Subject has Barrett's esophagus >3cm
• Cannot understand trial requirements or is unable to comply with follow-up schedule
• Pregnant 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.

Where it is running

• Keck Medical Center of USC — Los Angeles, California, United States
• Institute of Esophageal and Reflux Surgery — Lone Tree, Colorado, United States
• South Florida Reflux Center — Coral Springs, Florida, United States
• East Carolina University — Greenville, North Carolina, United States
• Esophageal Institute — Pittsburgh, Pennsylvania, United States
• University of Texas — Austin, Texas, United States

Full record on ClinicalTrials.gov

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