Clinical trial NCT04695171: LINX Reflux Management System or Fundoplication Clinical Study in Patients With Hiatal Hernia >3 cm
Official title: Cohort Registry on LINX Reflux Management System or Fundoplication Clinical Study in Patients With Hiatal Hernia >3 cm
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hiatal Hernia Large
Gastro Esophageal Reflux
Hiatal Hernia
Hiatal Hernia, Paraesophageal
Reflux, Gastroesophageal
Reflux Acid
Keywords: GERD
LINX
Fundoplication
MSA
Magnetic Sphincter Augmentation
MSAD
Magnetic Sphincter Augmentation Device
Lead sponsor: Foregut Research Foundation
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 450
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This clinical evaluation will be conducted at four U.S. investigational centers with up to one hundred and fifty(150) subjects per center (goal of 450 total). Corhort 1 will consist of 300 subjects who were implanted with the LINX® Reflux Management System in the manner described above more than 2 years prior to enrollment to this study. Cohort 2 will consist of 150 subjects who underwent a fundoplication more that 2 years prior to enrollment into this study with similar hiatal hernia size and similar effective esophageal motility.

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 construction more than 2 years prior to initial study visit.

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 Augmentation (MSA) using LINX placement or fundoplication construction more than 2 years prior to initial study visit. Subjects will be enrolled by invitation only by participating investigators. Enrollment will consist of 300 LINX MSA patients and 150 fundoplication patients with a total of 450 from 4 sites within the United States. Data will be collected for up to 6 years.The primary objective of this study is to determine the long-term incidence of hiatal hernia recurrence in patients who undergo hiatal hernia repair of a large (\>3 cm) hernia with LINX® device placement, and to compare this with hiatal hernia recurrence rates in patients who underwent hiatal hernia repair with fundoplication.

Eligibility criteria: Inclusion Criteria:

1. Subject must be at least 21 years of age and at least the minimum Age of Majority according to applicable state law.
2. 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.
3. Subject is willing and able to cooperate with follow-up examinations.
4. Subject has been informed of the study procedures and treatment and has signed an informed consent.

Exclusion Criteria:

1. The surgical procedure was completed as an emergency procedure
2. Currently being treated with another investigational drug or investigational device
3. Suspected or confirmed esophageal or gastric cancer
4. Subject has Barrett's esophagus \>3cm
5. Cannot understand trial requirements or is unable to comply with follow-up schedule
6. Pregnant or plans to become pregnant during the course of the study
7. 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)
8. Diagnosed psychiatric disorder (e.g. bipolar, schizophrenia, etc.), subjects that exhibit depression that are on appropriate medication(s) are allowable.

Primary outcomes:
measure: Incidence of Hiatal Hernia Recurrence
timeFrame: Up to 5 years post index procedure
Secondary outcomes:
measure: Incidence of Repeat Surgical Intervention
timeFrame: 5 years
measure: Understanding Patient Reported Symptom Control
timeFrame: 5 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
city: Lone Tree
country: United States
facility: Institute of Esophageal and Reflux Surgery
state: Colorado
city: Coral Springs
country: United States
facility: South Florida Reflux Center
state: Florida
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Pittsburgh
country: United States
facility: Esophageal Institute
state: Pennsylvania
city: Austin
country: United States
facility: University of Texas
state: Texas
Study officials:
affiliation: Principal Investigator
name: Reginald Bell, M.D.
role: PRINCIPAL_INVESTIGATOR
References: