Clinical trial: Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study (NCT01136980)

Eligibility criteria:
Inclusion Criteria:

          -  Age 18-80 years

          -  Dependent upon daily PPIs for > 6 months

          -  Troublesome symptoms, specifically heartburn or regurgitation, while on 40 mg of
             omeprazole or equivalent.

        Troublesome heartburn or regurgitation symptoms are those which occur a minimum of 2-3 days
        a week and are at least moderate in severity.

          -  Abnormal ambulatory pH study off PPI therapy for 7 days.

          -  Normal or near normal esophageal motility (by manometry)

          -  Hiatal hernia axial height is no larger than 2 cm and the transverse dimension should
             not exceed 2.5 cm

          -  Patient willing to cooperate with post-operative dietary recommendations and
             assessment tests

          -  Signed informed consent

        Exclusion Criteria:

          -  BMI > 35

          -  Hiatal hernia > 2 cm

          -  Esophagitis Los Angeles grade C or D

          -  Esophageal ulcer

          -  Esophageal stricture

          -  Esophageal motility disorder

          -  Pregnancy or plans for pregnancy in the next 12 months (in females)

          -  Immunosuppression

          -  ASA > 2

          -  Portal hypertension and/or varices

          -  History of previous resective gastric or esophageal surgery, cervical spine fusion,
             Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or
             dermatomyositis, eosinophilic esophagitis, or cirrhosis

          -  Active gastro-duodenal ulcer disease

          -  Gastric outlet obstruction or stenosis

          -  Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric
             emptying study if patient complains of postprandial satiety during assessment

          -  Coagulation disorders

          -  Interprocedural determination of anatomical presentation which in the opinion of the
             surgeon does not allow safe device introduction.
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 80 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