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

RecruitingOBSERVATIONAL
Enrollment

450

Participants

Timeline

Start Date

January 14, 2021

Primary Completion Date

January 31, 2027

Study Completion Date

January 31, 2028

Conditions
Hiatal Hernia LargeGastro Esophageal RefluxHiatal HerniaHiatal Hernia, ParaesophagealReflux, GastroesophagealReflux Acid
Interventions
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.

Trial Locations (6)

15224

ACTIVE_NOT_RECRUITING

Esophageal Institute, Pittsburgh

27858

RECRUITING

East Carolina University, Greenville

33065

RECRUITING

South Florida Reflux Center, Coral Springs

78712

RECRUITING

University of Texas, Austin

80124

RECRUITING

Institute of Esophageal and Reflux Surgery, Lone Tree

90033

RECRUITING

Keck Medical Center of USC, Los Angeles

Sponsors
All Listed Sponsors
lead

Foregut Research Foundation

OTHER