NCT04695171

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 336 (actual)
• Sponsor: Foregut Research Foundation · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hiatal Hernia Large
• Gastro Esophageal Reflux
• Hiatal Hernia
• Hiatal Hernia, Paraesophageal
• Reflux, Gastroesophageal
• Reflux Acid

Interventions

Type	Name	Description
DEVICE	LINX Reflux Management System	The LINX Reflux Management System consists of a series of titanium beads each with a magnetic core connected with independent titanium wires to form an annular shape when implanted. The attractive force of the magnetic beads is designed to provide additional strength to keep a weak lower esophageal sphincter (LES) closed. During swallowing, the magnetic beads slide away from each other on the independent titanium wire "links" to allow esophageal distention as the bolus passes by.
PROCEDURE	Fundoplication	A surgical procedure where the fundus of the stomach is wrapped around and sutured to the distal esophagus to restore the function of the lower esophageal sphincter in limiting stomach contents from refluxing into the esophagus.

Timeline

• Start date: 2021-01-14
• Primary completion: 2026-01-14
• Completion: 2026-01-14
• First posted: 2021-01-05
• Last updated: 2026-02-09

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study