Clinical trial: An Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Reflux (NCT02749071)

Eligibility criteria:
Inclusion Criteria:

          1. Able and willing to provide written informed consent

          2. Able and willing to comply with required study procedures and follow-up schedule

          3. 22 - 75 years of age at the time of informed consent

          4. Documented symptoms of gastroesophageal reflux disease (GERD) for longer than 6 months
             (regurgitation and/or heartburn which is defined as burning epigastric or substernal
             pain which responds to acid neutralization or suppression) which requires daily use of
             proton pump inhibitors (PPIs) or other anti-reflux drug therapy, who continue to have
             symptoms despite maximum medical therapy or are "intolerant" -severe side-effects
             (e.g. anaphylaxis or severe allergic reaction, recurrent C. difficile, severe
             hypomagnesaemia) to one PPI or mild/moderate side effect (e.g. nausea, vomiting,
             diarrhea or abdominal pain) to at least 2 PPIs of different chemical classes.

          5. Symptomatic improvement on PPI therapy demonstrated by a composite GERD-health-related
             quality of life (HRQL) score of ≥20 off PPI, and a ≥10 point improvement on PPI
             compared to the off PPI composite GERD-HRQL score. Patients who meet the definition
             above of PPI intolerant are not required to have ≥10 point improvement. The on-PPI
             score to satisfy this criterion will be the score from the GERD-HRQL assessment
             completed after resuming PPIs following the Baseline visit.

          6. Excessive lower esophageal acid exposure during pH monitoring (defined as distal
             esophageal pH < 4 for > 6.0% of the monitoring time) performed after at least 5 days
             off of PPIs and at least 2 days off of H2 blockers. At least 18 hour of esophageal pH
             recording will be considered adequate and inclusion will be based on the day (at least
             18 hours of valid data) with the highest acid exposure percentage time.

          7. Esophagitis ≤ Grade B (Los Angeles (LA) classification) as measured by upper endoscopy
             off PPI and H2 blockers for 10-14 days

          8. Esophageal body contraction amplitude > 30 mmHg for > 30% of swallows and > 30%
             peristaltic contractions on HRM or ≥ 30% peristaltic contractions with DCI >450.

          9. Suitable surgical candidate able to undergo general anesthesia and laparoscopic
             surgery

        Exclusion Criteria:

          1. Previous EndoStim LES System implant and/or implant attempt

          2. Previous surgery involving the gastroesophageal junction or the lead implant site,
             such as a Nissen fundoplication

          3. Previous endoscopic intervention for the treatment of GERD and/or Barrett's esophagus

          4. Hiatal hernia larger than 3 cm as determined by endoscopy

          5. History of gastroparesis

          6. Any non-GERD esophageal motility disorders that in the opinion of investigator
             precludes an anti-reflux procedure

          7. History of or known esophageal stricture or significant esophageal anatomic
             abnormalities (obstructive lesions, etc.)

          8. Barrett's esophagus or any grade of dysplasia

          9. Documented history of esophagitis Grade C or D (LA Classification)

         10. History of suspected or confirmed esophageal or gastric cancer

         11. Esophageal or gastric varices

         12. Symptoms of dysphagia more than once per week every week within the last 3 months

         13. Unable to tolerate withdrawal from H2 Blockers or PPI medications

         14. Suspected or known allergies to titanium, platinum, iridium, stainless steel,
             silicone, epoxy, or nylon

         15. Body mass index (BMI) > 35 kg/m2

         16. Any significant multisystem diseases

         17. Autoimmune or a connective tissue disorder (scleroderma, dermatomyositis,
             Calcinosis-Raynaud's-Esophagus Sclerodactyly Syndrome (CREST), Sjogren's Syndrome,
             Sharp's Syndrome, etc.) requiring therapy in the preceding 2 years

         18. 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

         19. Significant cardiac arrhythmia or ectopy or significant cardiovascular disease (i.e.
             unstable angina pectoris, hemodynamically significant valvular disease, severe
             congestive heart failure), or any cardiac therapeutic intervention within the last 6
             months.

         20. Significant cerebrovascular event within the last 6 months

         21. Existing implanted electrical stimulator (pacemaker, implantable cardioverter
             defibrillator, deep brain stimulator (DBS), bone growth or pelvic floor stimulators,
             drug pumps, etc.)

         22. 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

         23. Currently enrolled in other potentially confounding research

         24. Active infection as determined by the investigator

         25. History of any malignancy, other than basal cell carcinoma, in the last 2 years

         26. Life expectancy less than 3 years aa. Diagnosed major psychiatric disorder (bipolar,
             schizophrenia, etc.) bb. 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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 22 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