LINX Reflux Management System or Fundoplication Clinical Study in Patients With Hiatal Hernia >3 cm (NCT04695171) | Clinical Trial Compass
TerminatedNot Applicable
LINX Reflux Management System or Fundoplication Clinical Study in Patients With Hiatal Hernia >3 cm
Stopped: The study was terminated early. The sponsor will focus on prospective randomized controlled studies at this time. Funding removed.
United States336 participantsStarted 2021-01-14
Plain-language summary
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.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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
. 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.