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

Foregut Research Foundation

Status: Enrolling

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

Treatments: Device: LINX Reflux Management System; Procedure: Fundoplication

Study type: Observational

Funder types: Other

Identifiers

NCT04695171

TRX-2019-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

450 participants in 2 patient groups

Prior Primary Large Hiatal Hernia with LINX Placement MSA

Description:

Patients who were previously implanted with the LINX device during repair of a hiatal hernia \>3 cm \>2 years prior will be asked to complete a quality of life questionnaire at about 3 years and 5 years post procedure. Each participant will complete a barium swallow at 3 and 5 years to determine recurrence of hiatal hernia.

Treatment:

Device: LINX Reflux Management System

Prior Primary Large Hiatal Hernia with Fundoplication

Description:

Patients who previously underwent lower esophageal sphincter reconstruction by fundoplication during repair of a hiatal hernia \>3 cm \>2 years prior will be asked to complete a quality of life questionnaire at about 3 years and 5 years post procedure. Each participant will complete a barium swallow at about 3 and 5 years to determine recurrence of hiatal hernia.

Treatment:

Procedure: Fundoplication