Clinical trial: LINX Reflux Management System Clinical Study Protocol (NCT00776997)

Eligibility criteria:
Inclusion Criteria:

          -  Subject must be at least 18 years of age and at least the minimum Age of Majority
             according to applicable State or Country Law and must be less than 75 years of age,
             with a life expectancy > 3 years

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

          -  Documented typical symptoms of gastroesophageal reflux disease (GERD) for longer than
             6 months (regurgitation or heartburn which is defined as a burning epigastic or
             substernal pain which responds to acid neutralization or suppression)

          -  Patient requires daily proton pump inhibitor or other anti-reflux drug therapy

          -  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.

          -  Subjects with symptomatic improvement on proton-pump inhibitor (PPI) therapy
             demonstrated by a GERD-Health-Related Quality of Life (GERD-HRQL) score of ≤ 10 on
             proton-pump inhibitors and ≥ 15 off PPIs, or subjects with a ≥ 6 point improvement
             when comparing their on PPI and off PPI GERD-HRQL score

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

          -  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

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

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

        Exclusion Criteria:

          -  The procedure is an emergency procedure

          -  Currently being treated with another investigational drug or investigational device

          -  History of gastroesophageal surgery, anti-reflux procedures, or
             gastroesophageal/gastric cancer

          -  Any previous endoscopic anti-reflux intervention for GERD

          -  Suspected or confirmed esophageal or gastric cancer

          -  Any size hiatal hernia >3cm as determined by endoscopy

          -  Distal esophageal motility (average of sensors 3 and 4) is less than 35 mmHg
             peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences

          -  Esophagitis - Grade C or D (LA Classification)

          -  Body Mass Index (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

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

          -  Subject has esophageal or gastric varices

          -  Subject has history of or known Barrett's esophagus

          -  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

          -  Medical illness (i.e. congestive heart failure) that may cause the subject to be
             non-compliant with or able to meet the protocol requirements or is associated with
             limited life expectancy (i.e. less than 3 years)

          -  Diagnosed psychiatric disorder (e.g. bipolar, schizophrenia, etc.), subjects that
             exhibit depression that are on appropriate medication(s) are allowable.

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

          -  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 18 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