Clinical trial: RELIEF Europe Study (NCT02762487)

Eligibility criteria:
Inclusion Criteria:

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

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

          -  Documented pathologic esophageal acid exposure by pH monitoring per institution's
             standard of care (i.e. total distal ambulatory esophageal pH< 4 for ≥ 5.3% (BRAVO) or
             ≥4.5% (transnasal) or abnormal DeMeester Score (>14.72) within 12 months of proposed
             implantation date (After Sleeve Gastrectomy).

        NOTE: SUBJECTS SHALL HAVE DISCONTINUED ALL GERD MEDICATIONS FOR AT LEAST 7 DAYS PRIOR TO
        TESTING WITH THE EXCEPTION OF ANTACIDS, WHICH MAY BE TAKEN UP UNTIL THE MORNING OF THE
        VISIT.

          -  Chronic GERD symptoms despite maximum medical therapy for the treatment of reflux.

          -  Age ≥ 21 years

          -  At least 30% loss of excess weight from date of original LSG surgery.

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

          -  Patient has been informed of the study procedures and the treatment and has signed an
             informed consent form.

        Exclusion Criteria:

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

          -  Prior surgery in the area of the gastroesophageal junction (GEJ), including prior
             hiatal hernia repair.

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

          -  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).

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

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

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

          -  Distal amplitude <35 mmHg or <70% peristaltic sequences.

          -  Presence of esophagitis - Grade C or D (LA Classification). BMI >35.

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

          -  Diagnosed with Scleroderma.

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

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

          -  Patient has esophageal or gastric varices.

          -  Patient has Barrett's esophagus.

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

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

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

          -  Patient 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 21 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? Contradiction