Status:
RECRUITING
LINX Reflux Management System or Fundoplication Clinical Study in Patients With Hiatal Hernia >3 cm
Lead Sponsor:
Foregut Research Foundation
Conditions:
Hiatal Hernia Large
Gastro Esophageal Reflux
Eligibility:
All Genders
21+ years
Brief 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 constru...
Detailed Description
The cohort registry is both retrospective and prospective, multicenter surveillance of subjects who underwent a prior hiatal hernia repair and anti-reflux surgery with either Magnetic Sphincter Augmen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04695171
Start Date
January 14 2021
End Date
January 1 2028
Last Update
November 1 2024
Active Locations (6)
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1
Keck Medical Center of USC
Los Angeles, California, United States, 90033
2
Institute of Esophageal and Reflux Surgery
Lone Tree, Colorado, United States, 80124
3
South Florida Reflux Center
Coral Springs, Florida, United States, 33065
4
East Carolina University
Greenville, North Carolina, United States, 27858