Clinical trial: Feasibility Study for Evaluating the Effect of Electrical Stimulation on Lower Esophageal Sphincter Pressure and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease (NCT01578642)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? Contradiction