Clinical trial: The EndoGastric Solutions TEMPO Trial (NCT01647958)

Eligibility criteria:
Inclusion Criteria:

          1. Age 18-80 years;

          2. GERD for > 1 year;

          3. History of daily PPIs for > 6 months;

          4. At least daily bothersome medically refractory GERD symptom(s) other than heartburn on
             PPIs;

          5. Hill grade I and II at gastroesophageal junction;

          6. Proven gastroesophageal reflux by either endoscopy, ambulatory pH or barium swallow
             testing;

          7. Willingness to undergo pH testing;

          8. Willingness to cooperate with the postoperative diet;

          9. Availability for follow-up visits at 6, 12, 24, and 36 months;

         10. Willingly and cognitively signed inform consent

        Exclusion Criteria:

          1. BMI > 35 Hiatal hernia > 2c m in axial height and > 2 cm in greatest transverse
             dimension;

          2. Esophagitis grade C and D;

          3. Barrett's esophagus > 2 cm;

          4. Esophageal ulcer;

          5. Fixed esophageal stricture or narrowing;

          6. Portal hypertension and/or varices;

          7. Active gastro-duodenal ulcer disease; Gastric outlet obstruction or stenosis;

          8. Gastroparesis;

          9. Coagulation disorders;

         10. History of any of the following: resective gastric or esophageal surgery, antireflux
             surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical
             spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia,
             scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis;

         11. Pregnancy or plans of pregnancy in the next 12 months;

         12. Enrollment in another device or drug study that may confound the results
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
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