Clinical trial: Omega Cuff for GERD Feasibility Study (NCT04793035)

Eligibility criteria:
Inclusion Criteria:

          -  • Subject must be at least 22 years of age 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.

               -  Subject has documented typical symptoms of gastroesophageal reflux disease (GERD)
                  for longer than 6 months (regurgitation or heartburn that is defined as a burning
                  epigastric or substernal pain that responds to acid neutralization or
                  suppression).

               -  Subject 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 will have discontinued any GERD medications for
                  at least 10 days prior to testing.

               -  Subject has a 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 his/her on-PPI and off-PPI GERD-HRQL score.

               -  Subject has GERD symptoms in absence of PPI therapy (minimum 10 days).

               -  If the subject is of child-bearing potential, she 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.

               -  Subject is currently being treated with another investigational drug or
                  investigational device.

               -  Subject has a history of gastroesophageal surgery, anti-reflux procedures, or
                  gastroesophageal/gastric cancer.

               -  Subject has undergone any previous endoscopic anti-reflux intervention for GERD.

               -  Subject has suspected or confirmed esophageal or gastric cancer.

               -  Subject has 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.

               -  Subject has esophagitis Grade C or D (LA Classification).

               -  Subject has a Body Mass Index (BMI)>35.

               -  Subject has symptoms of dysphagia more than once per week within the last 3
                  months.

               -  Subject is diagnosed with Scleroderma or 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 a history of or known Barrett's esophagus.

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

               -  Subject is pregnant or nursing or plans to become pregnant during the course of
                  the study.

               -  Subject has a medical illness (e.g., congestive heart failure) that may cause the
                  subject to be non-compliant with or unable to meet the protocol requirements or
                  is associated with limited life expectancy (i.e., less than 3 years).

               -  Subject is diagnosed with a psychiatric disorder (e.g., bipolar, schizophrenia,
                  etc.); however, subjects who exhibit depression but are on appropriate
                  medication(s) may be included.

               -  Subject has suspected or known allergies to titanium, stainless steel, nickel, or
                  ferrous materials.

               -  Subject has an electrical implant or metallic abdominal implants.

               -  Subject is not a surgical candidate for open laparotomy.
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.
Subject must be at most 74 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