Ensayos clínicos

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.