Clinical trial: An Investigation of Electrical Stimulation on Gastroesophageal Reflux Disease (GERD) in Patients After Sleeve Gastrectomy (NCT02210975)

Eligibility criteria:
Inclusion Criteria:

          1. Subject is between 18 - 80 years of age.

          2. Subject underwent a sleeve gastrectomy minimum one year prior to enrollment (in order
             to have reached a stable weight loss plateau).

          3. Subject has a history of heartburn, regurgitation or both for >6 month prompting
             physician recommendation of continual daily use of PPI after sleeve gastrectomy.

          4. Baseline off-PPI GERD-HRQL score ≥ 20 following 10-14 days off PPI

          5. Baseline off-PPI GERD-HRQLscore is at least 5 points higher than the on-PPI score or a
             positive relationship between the occurrence of their primary symptom during the pH
             impedance monitoring (symptom association probability ≥ 95% or a SI score ≥ 50%) is
             present.

          6. Subject who are on standard medical therapy for 6 months or longer and experience
             discomfort or who are otherwise dissatisfied with GERD symptoms.

          7. Subjects with a GERD condition that in the opinion of the PI justifies a minimally
             invasive reversible procedure prior to attempting a more drastic procedure such as a
             gastric bypass.

          8. Subject has exhibited excessive lower esophageal acid exposure during 24-hour pH-metry
             of antisecretory therapy performed within 6 months of screening visit; pH < 4 for > 6%
             of total time.

          9. Subject has a resting LES end expiratory pressure ≥ 5mmHg on manometry performed
             within 6 months of enrollment.

         10. Subject has no esophagitis or esophagitis ≤ Grade C (LA classification) on upper
             endoscopy within 6 months of enrollment.

         11. Subject has esophageal body contraction amplitude > 30 mmHg for >30% of swallows and >
             30% peristaltic contractions on manometry.

         12. Subject has signed the informed consent form and is able to adhere to study visit
             schedule.

        Exclusion Criteria:

          1. Subject has any non-GERD esophageal motility disorders.

          2. Subject has evidence of obstruction or stricture in the gastric sleeve by a barium
             swallow and endoscopy.

          3. Subject has any significant multisystem diseases.

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

          5. Subject has Barrett's epithelium (> M2; >C1) or any grade of dysplasia.

          6. Subject has a hiatal hernia larger than 3 cm.

          7. Subject has a body mass index (BMI) greater than 35 kg/m2.

          8. Subject has Type 1 Diabetes Mellitus

          9. Subject has uncontrolled Type 2 Diabetes Mellitus (T2DM) defined as HbA1c >9.5 in the
             previous 6 months, or has T2DM for > 10 years.

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

         11. Subject has esophageal or gastric varices.

         12. Subject has significant cardiac arrhythmia or ectopy or significant cardiovascular
             disease.

         13. Subject has an existing implanted electrical stimulator (e.g., pacemaker, AICD).

         14. Subject requires chronic anticoagulant therapy.

         15. Subject has dysphagia or esophageal peptic stricture, excluding Schatzki's ring.

         16. Subject of child-bearing potential who is pregnant or intends to become pregnant
             during the trial period.

         17. Subject is currently enrolled in other potentially confounding research.

         18. History of any malignancy in the last 2 years.

         19. Subject has any condition that, at the discretion of the investigator, would preclude
             participation in the trial.

         20. Weight change of +/- 10% of the EWL (Excess Weight Loss) in the 3 months prior to
             enrollment.
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 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