Clinical trial: Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance (NCT01503476)

Eligibility criteria:
Inclusion Criteria:

          1. Subject age ≥ 18 years old

          2. Subject received an explanation about the nature of the study and agrees to provide
             written informed consent.

             Group A (healthy volunteers) Only

          3. Subject is an healthy volunteer

        Group B (symptomatic patients) Only 1. The subject was referred for pH monitoring procedure
        to detect acid reflux for at least one of the following reasons:

          -  Burning substernal chest pain (heartburn)

          -  Regurgitation of food or stomach contents

          -  Dysphagia

          -  Epigastric pain

          -  Non-erosive reflux disease (NERD)

        Exclusion Criteria:

        Group A and B-

          1. Subject has a cardiac pacemaker or other implanted electromedical device.

          2. Subject has any condition, which precludes compliance with study and/or device
             instructions.

          3. Women who are either pregnant or nursing at the time of screening, or are of
             child-bearing potential and do not practice medically acceptable methods of
             contraception.

          4. Subject suffers from life threatening conditions

          5. Subject currently participating in another clinical study which may interfere with
             study objectives, per physician discretion

             Additional exclusion criteria for Group B only

          6. Subject has prior abdominal surgery other than uncomplicated procedures that would be
             unlikely to lead to bowel obstruction based on the clinical judgment of the
             investigator

          7. Subject is schedule to undergo MRI examination within 30 days from pH monitoring
             procedure.

          8. Subject has known bleeding diathesis, strictures, severe esophagitis, varices and or
             obstructions -
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


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? Entailment