Clinical trial: Antireflux Ablation of the Cardia Mucosa vs Placebo for the Treatment of Gastroesophageal Reflux Disease (NCT04711655)

Eligibility criteria:
Inclusion Criteria:

          1. Age over 18 years.

          2. GERD symptoms lasting more than 6 months, not necessarily consecutive. They should at
             least have a typical GERD symptom (heartburn or regurgitation).

          3. Total acid exposure time> 6% in pH measurement study without PPI treatment.

          4. Patients who do not want to take PPIs or with chronic consumption, defined as PPI
             consumption of more than 6 months (consecutive or not) in the last 2 years.

          5. Response to PPI treatment, defined as an increase of> 10 points on the GERD-HRQL
             questionnaire 15 days after discontinuation of the PPI.

          6. Written informed consent to participate in the study.

        Exclusion Criteria:

          1. Patients with sliding hiatal hernia> 2 cm.

          2. Presence of only atypical GERD symptoms.

          3. Age> 75 years.

          4. Grade D peptic esophagitis.

          5. Body mass index> 35 40 kg / m2.

          6. Liver cirrhosis.

          7. Pregnancy.

          8. Incomplete relaxation of the LES in MAR (PIR> 15 mmHg).

          9. Absent peristalsis, defined as 100% failed waves with DCI <100 mmHg * cm * s in MAR.

         10. Esophagogastric surgery or previous endoscopic antireflux technique.

         11. Barrett's esophagus with dysplasia.

         12. Oncological disease.

         13. Esophageal strictures or ulcers.

         14. Severe cardiopulmonary comorbidity (ASA functional class IV-V).

         15. Previously known coagulopathy.

         16. Severe psychiatric disorder

         17. Refusal to participate in the study.
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 75 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