Clinical trial: A Study of the TransPyloric Shuttle™ (TPS™) for Weight Reduction in Obese Subjects (NCT01386905)

Eligibility criteria:
Inclusion Criteria:

          1. Male and female subjects between the ages of 18 to 55.

          2. BMI between 30 to 50 kg/m2. Subjects with BMI ≥ 35 to 50 kg/m2 inclusive, and subjects
             with a BMI of 30.0 to 34.9 kg/m2 are required to have one or more of the following
             obesity-related co-morbidities.

               1. Diabetes: controlled diabetic, and if on insulin, has been on the medication of
                  less than two years.

               2. Sleep apnea: Apnea/hypopnea index or AHI > 30 events/hour.

               3. Hypertension: arterial blood pressure > 140 mmHg systolic or > 90 mmHg diastolic

               4. Osteoarthritis of the hip or knee.

               5. Gastro Esophageal Reflux Disease (GERD): Persistent reflux that occurs more than
                  twice a week.

          3. History of stable weight (defined as a < 10% change in excess weight) for one year
             prior to screening visit.

          4. Female subjects of childbearing potential must have a negative urine pregnancy test
             and must agree to practice a medically acceptable form of birth control for the
             duration of their participation in the trial.

          5. History of obesity for at least five years.

          6. Subjects must be able to read and understand their native language at a level allowing
             the subject to understand and sign the informed consent prior to the performance of
             any study-specific procedure.

          7. Lives within the drawing area of the hospital.

          8. Willing and able to return for all study visits.

        Exclusion Criteria:

          1. Currently untreated thyroid and adrenal gland disease.

          2. Females who are either pregnant or breastfeeding.

          3. Insulin-dependent diabetic, where the subject has been on medication for more than two
             years.

          4. Uncontrolled hypertension defined as systolic blood pressure > 160 mmHg or diastolic
             blood pressure > 95 mmHg.

          5. Ischemic heart disease.

          6. Previous stroke.

          7. Previous myocardial infarct within 180 days of the study.

          8. Prior history of bariatric surgery, such as gastric bypass, or any surgery that has
             altered the esophagus, stomach, or pylorus, and restrictive procedures such as the
             LAP-BAND® or equivalent.

          9. Prior treatment with an intragastric balloon for the purpose of weight loss, where the
             balloon was removed less than 12 months prior to screening.

         10. A structural abnormality in the esophagus, pharynx (such as a stricture), or pylorus
             (such as an incompetent pylorus).

         11. Portal hypertension, cirrhosis, and/or varices.

         12. Inflammatory disease, such as Crohn's disease, where the disease is affecting the
             stomach.

         13. Acute abdominal infections.

         14. Active gastric or duodenal ulcer.

         15. A history of severe dyspepsia or gastric or duodenal ulcer disease.

         16. After treatment for H. pylori, patient still tests positive for H. pylori.

         17. Evidence of erosive esophagitis.

         18. Subject with a hiatal hernia ≥ 2 cm.

         19. Subjects with motility disorders of the GI tract such as esophageal motility
             disorders, gastroparesis diabeticorum, or intractable constipation.

         20. Use of any prescription or over-the-counter weight loss medication, including herbal
             supplements, within three months of TPS device placement.

         21. Subjects requiring continuous therapy with known ulcerogenic medication (e.g. aspirin,
             including 80 mg ASA or NSAIDs).

         22. Subjects on anticoagulant therapy, such as those taking Coumadin, Warfarin, Heparin or
             Plavix.

         23. Subjects unable to take a daily 40+ mg dose of Nexium or generic equivalent or 800+
             mcg of Misoprostol or general equivalent.

         24. Clinically significant abnormal laboratory values or EKG that make the subject a poor
             study candidate in the opinion of the investigator.

         25. Subjects with autoimmune connective tissue disorders.

         26. A history of cardiac arrhythmia or severe cardiac disease (NYHA Class III or IV).

         27. Cannot walk at least 0.8 kilometers per day (10 minutes of continuous walking).

         28. Subjects who have started on a prescribed concomitant medication regimen within the
             last three weeks, and/or whose concomitant medication regimen is expected to change
             during the course of the study, and where the Investigator determines the medication
             may affect the study outcome.

         29. Treatment for drug abuse, alcohol abuse, or inpatient psychiatric treatment within the
             past year.

         30. Any medical condition (including psychiatric disease) that would interfere with the
             interpretation of the study results, the conduct of the study, or would not be in the
             best interest of the subject.

         31. A score of ≥ 10 on the Patient Health Questionnaire 9 (PHQ-9), indicating moderate
             depression.

         32. Subjects who are in a dysfunctional relationship (e.g. an alcoholic spouse, the victim
             of sexual, verbal, or physical abuse, etc.).

         33. Participation in a trial of an investigational drug or device within 30 days prior to
             Screening Visit or plans to enroll in an investigational drug or device trial at any
             time during this study.

         34. Works for BAROnova or the study doctor or is directly-related to anyone that works for
             BAROnova or the study doctor.
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 55 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Entailment