Feasibility Study for Evaluating the Effect of Electrical Stimulation on Lower Esophageal Sphincter Pressure and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease

Inclusion Criteria:

• Subject is between 21 - 65 years of age.
• Subject has a history of heartburn, regurgitation or both for > 6 months prompting physician recommendation of continual daily use of PPI before study entry.
• Baseline GERD-HRQL heartburn score of ≥ 20 off PPI assessed during the run-in phase.
• Subject has an American Society of Anesthesiologists (ASA) Physical Status Classification I or II (or comparable local classification if any).
• Subject has demonstrated satisfactory symptomatic response to a previous course of GERD therapy (≥ 2 weeks); GERD HRQL heartburn score improvement of ≥ 10 on therapy as assessed during the run in phase.
• Subject has exhibited excessive lower esophageal acid exposure during 24-hour pH-metry off antisecretory therapy performed within 6 months of enrollment; pH < 4 for > 5% of total or > 3% of supine time.
• Subject has a resting LES end expiratory pressure > 5mm Hg and < 15 mm Hg on a high resolution manometry within 6 months of enrollment.
• Subject has esophagitis ≤ Grade C (LA classification) on upper endoscopy within 6 months of enrollment.
• Subject has esophageal body contraction amplitude > 30 mmHg for > 70% of swallows and > 50% peristaltic contractions on high resolution manometry.
• Subject has signed the informed consent form.

Exclusion Criteria:

• Subject has non-GERD esophageal motility disorders.
• Subject has gastroparesis.
• Subject has significant multisystem diseases.
• Subject has scleroderma requiring therapy in the preceding 2 years .
• Subject has dermatomyositis requiring therapy in the preceding 2 years.
• Subject has Calcinosis-Raynaud's-esophaguschlerodactyly syndrome requiring therapy in the preceding 2 years.
• Subject has Sjogren's Syndrome requiring therapy in the preceding 2 years.
• Subject has Sharp's Syndrome requiring therapy in the preceding 2 years.
• Subject has persistent esophagitis greater than LA grade C.
• Subject has Barrett's epithelium (> M2; >C1) or any dysplasia.
• Subject has a hiatus hernia larger than 3 cm.
• Subject has a body mass Index greater than 35 kg/m2 .
• Subject has Type 1 diabetes mellitus
• Subject has uncontrolled Type 2 diabetes mellitus (T2DM) defined as HbA1c >9.5 in the previous 6 months, or has T2DM for > 10 years.
• Subject has an autoimmune disorder requiring therapy in the preceding 2 years.
• Subject has suspected or confirmed esophageal or gastric cancer.
• Subject has esophageal or gastric varices.
• Subject has significant cardiac arrhythmia or ectopy or significant cardiovascular disease.
• Subject has an existing implanted electrical stimulator (e.g., pacemaker).
• Subject requires chronic anticoagulant therapy.
• Subject has dysphagia or esophageal peptic structure, excluding Schatzki's ring.
• Subject is pregnant or intends to become pregnant during the trial period.
• Subject is currently enrolled in other potentially confounding research.
• Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
• History of any malignancy in the last 2 years
• History of previous esophageal or gastric surgery, including nissen fundoplication