Clinical trial: Endomina Suturing Device as a Treatment of GERD. (NCT03999502)

Eligibility criteria:
Inclusion Criteria:

          -  1. Subject is 21 - 70 years of age at the time of informed consent 2. Subject has
             documented symptoms of GERD (heartburn and/or regurgitation) for longer than 12
             months, which respond at least partially to proton pump inhibitors (PPIs) 3. Subject
             is under continuous PPI therapy for at least 6 months 4. Subject has a diagnosis of
             GERD based on at least 2 of the following criteria:

               1. Past demonstration of reflux esophagitis grade A, B or C (LA classification)

               2. Abnormal esophageal acid exposure during esophageal pH-impedance monitoring
                  (defined as distal esophageal pH < 4 for > 4 % of the monitoring time) performed
                  after at least 7 days off of PPIs

               3. Positive symptom association between GERD symptoms and reflux episodes (symptom
                  association probability ≥ 95%) demonstrated at pH-impedance monitoring)

        Exclusion Criteria:

          -  Subjects who meet any of the following exclusion criteria cannot be enrolled in the
             study:

               1. Subject underwent previous surgery involving the gastroesophageal junction, such
                  as a Nissen fundoplication

               2. Subject underwent previous endoscopic intervention for the treatment of GERD
                  and/or Barrett's esophagus

               3. Subject has a hiatal hernia larger than 3 cm as determined by endoscopy

               4. Subject has history of gastroparesis

               5. Subject has any non-GERD esophageal motility disorders that in the opinion of
                  investigator precludes an anti-reflux procedure

               6. Subject has history of or known esophageal stricture or significant esophageal
                  anatomic abnormalities (obstructive lesions, etc.)

               7. Subject has Barrett's epithelium or any grade of dysplasia

               8. Subject has documented history of esophagitis Grade D (LA Classification)

               9. Subject has a history of suspected or confirmed esophageal or gastric cancer

              10. Subject has esophageal or gastric varices

              11. Subject has symptoms of dysphagia more than once per week every week within the
                  last 3 months

              12. Subject is unable to tolerate withdrawal from PPI medications

              13. Subject has a body mass index (BMI) > 35 kg/m2

              14. Subject has any significant multisystem diseases

              15. Subject has an autoimmune or a connective tissue disorder (scleroderma,
                  dematomyositis, Calcinosis-Raynaud's-Esophagus Sclerodactyly Syndrome (CREST),
                  Sjogren's Syndrome, Sharp's Syndrome, etc.) requiring therapy in the preceding 2
                  years

              16. Subject has Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus
                  (T2DM) defined as HbA1c > 9.5 in the previous 6 months or at screening/baseline

              17. Subject has had a significant cerebrovascular event within the last 6 months

              18. Female subject of child-bearing potential and is pregnant or nursing, or intends
                  to become pregnant during the trial period, who is not using a reliable form of
                  birth control

              19. Subject is currently enrolled in other potentially confounding research

              20. Subject has an active infection as determined by the investigator

              21. Subject has a history of any malignancy in the last 2 years

              22. Subject has a life expectancy less than 3 years

              23. Subject has a diagnosed major psychiatric disorder (bipolar, schizophrenia, etc.)

              24. Subject has any condition that, at the discretion of the investigator or sponsor,
                  would interfere with accurate interpretation of the study endpoints or preclude
                  participation in the trial

              25. Subject has a diagnosis of eosinophilic esophagitis
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 70 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