Clinical trial: A New System for GERD Diagnosis and Treatment (NCT03600974)

Eligibility criteria:
Inclusion Criteria:

          1. Male or Female aged ≥18 years

          2. Subjects with refractory reflux symptoms to PPIs standard treatment as follows:

             2.1 Ongoing heartburn symptom with or without these GERD-related symptoms :
             Regurgitation, Non-cardiac chest pain, Epigastric pain, Belching, Bloating, Satiety,
             Sore throat, Cough, Laryngitis, Hoarseness, Nausea, Vomiting, Dysphagia, Odynophagia,
             Weight loss.

             2.2 Ongoing heartburn symptom with or without erosion ≥ grade A according to LA
             Classification.

          3. Decided to participate and signed on an informed consent form willingly.

        Exclusion Criteria:

          1. Existence of upper gastrointestinal bleeding or active gastroduodenal ulcer at
             screening.

          2. History of operation in esophagus, stomach or duodenum.

          3. Primary esophageal motility disease, Achalasia, Scleroderma, Esophageal/ pyloric
             stricture, Primary esophageal spasm, Barrett's esophagus ≥ 3 cm, Zollinger-Ellison
             syndrome.

          4. Infectious or inflammatory bowel disease, Severe malabsorption, Severe chronic heart
             failure, cardiovascular disease, renal failure, COPD, asthma, liver cirrhosis.

          5. History of cancer within 5 years, except completely recovered skin cancer ALT or AST ≥
             Upper limit of normal range X 3.

          6. Need antibiotics due to severe infection.

          7. Pregnant or breast-feeding women.

          8. Conversation impairment because of alcohol, drug addiction or mental illness, etc.

          9. Inability to record diary card

         10. In investigator's judgement
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 90 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? Entailment