Clinical trial: Evaluation of Safety and Effectiveness of the RefluxStop Device in the Management of GERD (NCT02759094)

Eligibility criteria:
Inclusion Criteria:

          -  Subject's age >= 18 years and <= 75 years

          -  Subject is able to undergo general anaesthesia and is a suitable laparoscopic surgical
             candidate

          -  Subject is willing and able to participate

          -  Subject has provided written informed consent after being informed of the study
             procedure and risks prior to any study-related events

          -  Subject has documented typical GERD symptoms present for > 6 months which respond to
             PPIs as anti-GERD medication. Typical symptom of GERD is defined as heartburn, which
             is a burning epigastric or substernal pain

          -  Subject requires daily PPI anti GERD medication

          -  Subject has a 24-hour pH monitoring proven GERD performed taken off any anti reflux
             medication or after discontinuation for at least 7 days prior to testing. Total distal
             oesophageal pH must be <= 4 for >= 4.5% if time during a 24-hour monitoring

        Exclusion Criteria:

          -  Subject is currently participating in another study involving investigational drugs or
             devices

          -  Subject has a history of gastro oesophageal surgery, anti-reflux or bariatric
             procedure

          -  Subject has a history of endoscopic anti-reflux intervention

          -  Subject has a history or a suspicion of oesophageal or gastric cancer

          -  Subject has a history of major psychiatric disorder

          -  Presence of a para-oesophageal hernia or sliding hernia of > 3cm determined on
             endoscopy

          -  Presence of an oesophagitis grade C or D according to the Los Angeles classification

          -  Presence of oesophageal dysmotility disorder such as but not limited to sclerodermia,
             achalasia, Nutcracker oesophagus

          -  Presence of oesophageal stricture or stenosis

          -  Presence of delayed gastric emptying

          -  Presence of oesophageal or gastric varies

          -  Subject has a body mass index (BMI) > 35kg/m2

          -  Female patients who are pregnant or nursing

          -  Subjects who are unable to comply with the protocol requirements

          -  Subjects with limited life expectancy (< 3 years)

          -  Intra-operative findings that may preclude conduct of the study procedures
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? 0