Clinical trial: LINX Reflux Management System in Subjects With GERD Who Have Previously Undergone a Laparoscopic Sleeve Gastrectomy (NCT02429830)

Eligibility criteria:
INCLUSION CRITERIA

        Subjects included in the study must meet all the following criteria:

          1. Age >22 years

          2. Laparoscopic sleeve gastrectomy (LSG) for obesity >12 months prior to proposed device
             implantation date.

          3. Subject is a surgical candidate, i.e. is able to undergo general anesthesia and
             laparoscopic surgery.

          4. Documented typical symptoms of GERD for longer than 6 months (regurgitation or
             heartburn which is defined as a burning epigastric or substernal pain which responds
             to acid neutralization or suppression).

          5. Subject requires daily proton pump inhibitor or other anti-reflux drug therapy.

          6. Total distal ambulatory esophageal pH must meet the following criteria: pH <4 for
             >4.5% of the time. Note: Subjects shall have discontinued any GERD medications for at
             least 7 days prior to testing, with the exception of antacids up to the morning of
             testing.

          7. Subjects with symptomatic improvement on PPI therapy demonstrated by a GERD-HRQL score
             of <10 on PPI and >15 off PPI, or subjects with a >6 point improvement when comparing
             their on PPI and off PPI GERD-HRQL scores.

          8. GERD symptoms, in absence of PPI therapy (minimum 7 days).

          9. If the subject is of child bearing potential must have a negative pregnancy test
             within one week prior to implant and must agree to use effective means of birth
             control during the course of the study.

         10. Subject is willing and able to cooperate with follow-up examinations

         11. Subject has been informed of the study procedures and the treatment and has signed an
             informed consent form.

        EXCLUSION CRITERIA

        Subjects should be excluded from the study based on the following criteria:

          1. The procedure is an emergency procedure.

          2. Suspected or known allergies to titanium, stainless steel, nickel, or ferrous
             materials.

          3. Presence of ˃3 cm hiatal hernia as determined by endoscopy or barium esophagram.

          4. Subject had any major complications related to the laparoscopic sleeve gastrectomy
             that may interfere with, or increase the risks of the LINX procedure (such as, but not
             limited to, leaks from the gastric remnant and infection at the sleeve gastrectomy)

          5. Plans to surgically revise the gastric pouch (either known preoperatively or decided
             intraoperatively)

          6. Currently being treated with another investigational drug or investigational device.

          7. Suspected or confirmed esophageal or gastric cancer or prior gastric or esophageal
             surgery or endoscopic intervention for GERD (with the exception of sleeve
             gastrectomy).

          8. Distal amplitude <35 mmHg or <70% peristaltic sequences (if using Conventional
             Manometry). -or- If using High Resolution Manometry (exclude for any of the
             following):

               -  Distal Contractile Integral (DCI) ≤ 450 mmHg·s·cm or

               -  ≥ 50% ineffective swallows or

               -  ≥ 50% fragmented swallows (Fragmented swallows are defined as those with a ≥ 5cm
                  break [large] in peristaltic integrity).

          9. Presence of esophagitis - Grade C or D (LA Classification).

         10. BMI >35.

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

         12. Diagnosed with Scleroderma.

         13. Diagnosed with an esophageal motility disorder such as but not limited to achalasia,
             nutcracker esophagus, or diffuse esophageal spasm or hypertensive LES.

         14. Subject has a history of or known esophageal stricture or gross esophageal anatomic
             abnormalities (Schatzki's ring, obstructive lesions, etc.)

         15. Subject has esophageal or gastric varices

         16. History of/or known Barrett's esophagus. Note: The diagnosis of Barrett's esophagus
             requires both endoscopic and histologic evidence of metaplastic columnar epithelium.
             Endoscopically, there must be columnar epithelium within the esophagus.
             Histologically, the epithelium must be metaplastic, as defined by the presence of
             goblet cells.by

         17. Subject cannot understand trial requirements or is unable to comply with follow-up
             schedule

         18. Pregnant or nursing, or plans to become pregnant during the course of the study.

         19. Any reason which the Investigator believes may cause the subject to be non-compliant
             with or unable to meet the protocol requirements.

         20. Subject has an electrical implant or metallic, abdominal implants.
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.


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? 0