Registry of Outcomes From AntiReflux Surgery

This is a prospective, multi center, observational database of patients that are having
surgical laparoscopic antireflux procedure and/or hiatal hernia repair, including
laparoscopic Nissen fundoplication and Magnetic Sphincter Augmentation with the LINX device.
Patients meeting registry inclusion and exclusion will be followed for 5 years with
standardized quality of life surveys and appropriate standard of care testing. Up to 40 sites
will participate with total enrollment of 1000 patients.

The main objectives are to collect data from everyday clinical practices and track patients
from preoperative assessments to 5 years post surgical intervention to evaluate symptoms,
medication use and side effects.

Inclusion Criteria:

- Subject must be at least 21years of age and at least the minimum Age of Majority
according to applicable state law.

- Subject is a suitable surgical candidate, i.e. is able to undergo appropriate
anesthesia and endoscopic procedure or laparoscopic surgery.

- Appropriate indications for and documentation of disease process requiring surgery.
(Documented gastroesophageal reflux disease by accepted endoscopic or ambulatory
reflux monitoring criteria, or have a hiatal hernia that meets accepted criteria for
repair (e.g. large paraesophageal hernia with chest pain)).

- Subject is willing and able to cooperate with follow-up examinations

- Subject has been informed of the study procedures and treatment and has signed an
informed consent for the study.

Exclusion Criteria:

- Suspected or confirmed esophageal or gastric cancer.

- Cannot understand trial requirements or is unable to comply with follow-up schedule

- Pregnant or nursing, or plans to become pregnant during the course of the study

- 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)

- Diagnosed psychiatric disorder (e.g. bipolar, schizophrenia, etc.), subjects that
exhibit depression that are on appropriate medication(s) are allowable.