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

Recruiting

• Conditions: Hiatal Hernia Large; Gastro Esophageal Reflux; Reflux Acid; Hiatal Hernia; Reflux, Gastroesophageal; Hiatal Hernia, Paraesophageal
• Interventions: Device: LINX Reflux Management System; Procedure: Fundoplication

• Registration Number: NCT04695171
• Lead Sponsor: Foregut Research Foundation

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.

Study Timeline

• Study First Submitted: 2020-12-31
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-05
• Study Start: 2021-01-14
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Primary Completion: 2027-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prior Primary Large Hiatal Hernia with LINX Placement MSA	LINX Reflux Management System	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.
Prior Primary Large Hiatal Hernia with Fundoplication	Fundoplication	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Hiatal Hernia Recurrence	Up to 5 years post index procedure	The primary objective of this study is to determine the long-term incidence of hiatal hernia recurrence in patients who undergo primary 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 undergo hiatal hernia repair with fundoplication.

Secondary Outcome Measures

Name	Time	Method
Incidence of Repeat Surgical Intervention	5 years	A secondary objectives are to determine the incidence of repeat surgical intervention with recurrent hernias in patients who received a LINX verses fundoplication.
Understanding Patient Reported Symptom Control	5 years	A secondary objective is to understand patient-reported symptom control including PPI use, occurrence rate of gas and bloating, and ability to belch and vomit as measured by comparison of pre- and post-operative satisfaction and ROARS Questionnaire (GERD-Health related quality of life \[HRQL\]) surveys during multiple follow-up time points.

Trial Locations

Locations (6)

South Florida Reflux Center; 🇺🇸 Coral Springs, Florida, United States

Institute of Esophageal and Reflux Surgery; 🇺🇸 Lone Tree, Colorado, United States

East Carolina University; 🇺🇸 Greenville, North Carolina, United States

Keck Medical Center of USC; 🇺🇸 Los Angeles, California, United States

Esophageal Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Texas; 🇺🇸 Austin, Texas, United States