RETHINK REFLUX Registry

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

The RETHINK REFLUX Registry is a post-market prospective, multi-center, observation, single arm, long-term safety surveillance registry of subjects implanted with the LINX device. The primary objective of the study is to confirm the long-term safety profile of the LINX device and procedure (implant/explant) up to 10 years post-implant.

Eligibility

Primary outcome measure(s)

• Safety - Adverse Events — 10 years
  Adverse events related to the LINX device and/or procedure (implant/explant) limited to: * All related serious adverse events * All related adverse events of dysphagia and or odynophagia requiring treatment (only) * LINX migration * LINX erosion
• Safety - Explant/Removal — 10 years
  LINX explant/removal
• Safety - Hiatal Hernia Reoccurrence — 10 years
  Hiatal hernia requiring repair (occurring after the LINX implant)

Trial sites (28)