Clinical trial: Resolution of Comorbidities, Safety and Efficacy of Greater Curvature Plication in Obese Patients. (NCT01512940)

Eligibility criteria:
Inclusion Criteria:

          1. Subject is willing to give consent and comply with evaluation and treatment schedule;

          2. 18 to 65 years of age (inclusive);

          3. Have a BMI > 27 with one or more significant co-morbid medical conditions which are
             generally expected to be improved, reversed, or resolved by weight loss. These
             conditions may include but are not be limited to -

               -  Hyperlipidemia

               -  Type 2 diabetes

               -  Mild obstructive sleep apnea

               -  Hypertension

               -  Osteoarthritis of the hip or knee

          4. Agree to refrain from any type of weight-loss drug (prescription or OTC) or elective
             procedure that would affect body weight for the duration of the trial;

          5. HbA1C < 11%

          6. For subjects who have Type 2 diabetes, the anti-diabetic medication regimen is no more
             complex than oral metformin plus one oral sulfonylurea plus once daily insulin
             injection.

          7. Ability to self pay for the procedure and follow up.

        Exclusion Criteria:

          1. Previous malabsorptive or restrictive procedures performed for the treatment of
             obesity;

          2. Scheduled concurrent surgical procedure, with the exception of SOC liver biopsy;

          3. Women of childbearing potential who are pregnant or lactating at the time of screening
             or at the time of surgery;

          4. Any condition which precludes compliance with the study;

          5. History or presence of pre-existing autoimmune connective tissue disease

          6. Use of prescription or over the counter weight reduction medications or supplements
             within thirty days of the Screening Visit or the duration of study participation.

          7. Psychiatric disorders that may affect compliance with the clinical trial, including
             dementia, active psychosis, severe depression requiring > 2 medications, or history of
             suicide attempts. Any condition which places the subject at undue risk for the
             procedure (surgeon's discretion).
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 65 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