Clinical trial: Registry to Compare Two Surgical Treatments for GERD (NCT02211105)

Eligibility criteria:
Inclusion Criteria:

          -  GERD symptoms (heartburn, defined by a sub-sternal burning discomfort arising from the
             upper abdomen into the chest, and or regurgitation, defined as the effortless arising
             of liquid material into the chest or mouth) two or more times a week (when not on
             anti-secretory medication) that adversely affects the patient's quality of life.
             Additionally, patients will have to have responded to medical therapy (adequate relief
             of symptoms) as indicated by GERD-HRQL and regurgitation scores on medical therapy. In
             this context, scores ≤ 2 on each GERD-HRQL and regurgitation question (while on
             medication) indicate absence of daily bothersome symptoms and therefore these patients
             are considered responsive to medical therapy. Furthermore, patients will have to have
             objective evidence of GERD documented (esophagitis on endoscopy or pathological
             intraesophageal acid exposure on prolonged ambulatory esophageal pH monitoring).

          -  Age 18-80 years

          -  Ability to give informed consent

          -  Regular access to a telephone

          -  Meet the clinical criteria for treatment of GERD with TIF or LNF and undergo TIF or
             LNF within 90 days of providing consent.

               -  Dependent upon PPIs for control of heartburn for > six months or patient
                  determined to have an inadequate response of regurgitation symptoms despite
                  heartburn control with PPIs

               -  Hiatal hernia axial length is no larger than 2 cm and the transverse dimension
                  should not exceed 2.0 cm

               -  Gastroesophageal junction with a Hill Grade I-II

                  --- Patient willing to provide informed consent, cooperate with post-operative
                  dietary recommendations and follow-up assessment tests

               -  Objective documentation of pathological acid-reflux by either a) increased
                  intraesophageal acid exposure on prolonged ambulatory esophageal pH monitoring
                  (pH<4 for 4.5% or greater of the time) with or without impedance b) or the
                  presence of erosive esophagitis (LA Grade A or B) on endoscopy

               -  Absence of a severe esophageal motility disorder (note: mild abnormalities in
                  esophageal motility are common in GERD such as small breaks, etc.) including
                  achalasia, esophagogastric junction outflow obstruction, frequent failed
                  peristalsis, diffuse esophageal spasm, nutcracker or jackhammer esophagus etc. on
                  high-resolution esophageal manometry using the Chicago classification system or
                  evidence of incomplete bolus clearance on 30% or more of swallows by impedance
                  testing.

        Exclusion Criteria:

          -  Hiatal hernia > 2 cm (defined as longitudinal length measured endoscopically between
             the proximal margin of the gastric folds and the diaphragmatic pinch)

          -  Esophagitis LA Grade C or D

          -  Presence of troublesome atypical symptoms

          -  Barrett's esophagus greater than 2 cm in length or with any dysplasia

          -  Esophageal stricture or severe esophageal motility disorder

          -  History of previous resective gastric or esophageal surgery, cervical spine fusion,
             Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or
             dermatomyositis, eosinophilic esophagitis, cirrhosis or any other uncontrolled
             systemic disease

             --. Active gastro-duodenal ulcer disease

          -  Gastric outlet obstruction or stenosis

          -  Gastroparesis or delayed gastric emptying confirmed by a four hour solid-phase gastric
             emptying study

          -  Body Mass Index (BMI) > 35

          -  Pregnancy or plans for pregnancy within 12 months of the procedure

          -  Portal hypertension and/or varices

          -  New York Heart Association classification of III or IV.

          -  Coagulation disorders

          -  Intraprocedural determination of anatomical presentation which in the opinion of the
             surgeon does not allow safe performance of the procedure

          -  Enrollment in another device or drug study that may confound result
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? 0