Table 1.

Inclusion and exclusion criteria

Inclusion criteria	Exclusion criteria
Age ≥ 18 years old and typical persistent GERD symptoms (heartburn, regurgitation, or both). All patients showed symptomatic improvement with PPI and wanted to discontinue their GERD medications Baseline GERD-HRQL heartburn score of ≤11 on PPI and ≥20 off PPI (all GERD-related drugs were stopped for a minimum of 7 days minimum before completion of the off-medication GERD-HRQL questionnaire) Pathologic esophageal acid exposure at pH testing using the Bravo pH test (baseline 24-h pH, ≥4% of the time with a pH ≤ 4.0); a standard meal consisting of a hamburger, cheeseburger or chicken burger, French fries, and a milkshake was consumed within each 24-h period of the 48-h pH monitoring A negative pregnancy test for females of childbearing potential within 1 week before treatment	Dysphagia
	Morbid obesity (BMI > 35 kg/m²)
	Severe esophagitis (grade C or D LA classification)
	Previous esophagogastric surgery, antireflux procedures, or gastroesophageal or gastric cancer
	Hiatus hernia > 3 cm
	Barrett’s esophagus > 2 cm
	Ineffective esophageal motility (defined as amplitudes of esophageal peristalsis of <30 mmHg > 50% of the time)
	Esophageal or gastric varices
	Esophageal strictures
	Increased anesthesia risk (ASA Physical Status Classification 3 or 4)
	Immunocompromised status
	Stroke or transient ischemic neurologic attach within the 6 months before enrollment
	A significant gastrointestinal bleed with the 6 months before enrollment
	Other significant disease that may cause patient noncompliance
	Coagulation disorder
	Simultaneously participation in another drug or device study

GERD gastroesophageal reflux disease, BMI body mass index, HRQL health-related quality of life, LA Los Angeles, PPI proton pump inhibitor, ASA American Society of Anesthesiology

Note: The primary reason for screen failure was due to disqualifying GERD-HRQL scores either off or on PPIs