Clinical trial: An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter (NCT01058070)

Eligibility criteria:
Inclusion Criteria:

          -  Age ≥ 18 years, < 85 years, life expectancy > 3yrs.

          -  Documented history of GERD symptoms such as heartburn and/or regurgitation.

          -  On daily PPI treatment for at least 3-months.

          -  Responsive to PPI treatment.

          -  GERD symptoms, in absence of PPI therapy (minimum 10 days).

          -  Ambulatory Esophageal pH < 4 for ≥ 5% time or pH < 4 for ≥ 3% time in supine position.

          -  Patient is a surgical candidate.

          -  Patient is willing and able to cooperate with follow-up examinations.

          -  Patient has been informed of the study procedures and the treatment and has signed an
             informed consent form and provided authorization to use and disclose information for
             research purposes (HIPAA).

        Exclusion Criteria:

          -  The procedure is an emergency procedure.

          -  Patient is currently being treated with another investigational drug or
             investigational device.

          -  Patient has had prior gastric or esophageal surgery.

          -  Patient has had any previous endoscopic intervention for GERD

          -  Patient has suspected or confirmed esophageal or gastric cancer.

          -  Patient has any size paraesophageal hiatal hernia or sliding hiatal hernia ≥3cm.
             (Investigator to identify and record type of hiatal hernia at the time of assessment
             (i.e. para-esophageal, sliding)).

          -  Patient's esophageal motility is less than 35 mmHg peristaltic amplitude on wet
             swallows or > 30% failed (non-propulsive) peristaltic sequences.

          -  Patient has esophagitis - Grade B, C, D (LA Classification).

          -  Patient has Barretts Esophagus.

          -  Patient has BMI > 35.

          -  Patient has symptoms of dysphagia or indications of dysphagia from barium esophagram.

          -  Patient has Scleroderma and/or Achalasia.

          -  Patient has an esophageal stricture or gross esophageal anatomic abnormalities
             (obstructive lesions, etc.).

          -  Patient has an electrical implant or metallic, abdominal implant(s).

          -  Patient cannot understand trial requirements or is unable to comply with follow-up
             schedule.

          -  Patient is pregnant or nursing, or plans to become pregnant.

          -  Patient has a psychiatric disorder.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 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