Ensayos clínicos

Inclusion Criteria:

Adults who are receiving the POSE2 as part of the main study on POSE2 safety and feasibility (IRB 19-001254).  Inclusion criteria are the same as those of the main study on POSE2 safety and feasibility (IRB 19-001254), with the addition that they must be able to safely undergo non-contrasted MRI testing.

• Provision of signed and dated informed consent form.
• Subject agrees to be compliant with study requirements and adhere to post-operative dietary & exercise recommendations for the duration of the study.
• Subjects between the ages of 22-60 years old.
• If female, be either post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum HCG at screening/baseline.
• Have a Body Mass Index (BMI) of ≥ 35 and < 40 with one or more obesity related co-morbid conditions (defined by 1991 NIH Guidelines (Appropriateness Criteria for Bariatric Surgery: Beyond the NIH Guidelines)).
• Pre-diabetes – Fasting plasma glucose test > 100 mg/dl but ≤ 125 or oral glucose tolerance test ≥ 140 mg/dl but < 200.
• Diabetes – Individuals taking insulin and/or oral hypoglycemic medications or have a fasting glucose > 126 mg/dl.
• Hypertension – SBP >140 or DBP > 90 or the use of an antihypertensive medication.
• Dyslipidemia – Triglycerides > 250 mg/dl or cholesterol > 220 mg/dl or HDL < 35 mg/dl or LDL > 200 or use of lipid lowering medications.
• Sleep Apnea – A formal sleep study test consistent with this diagnosis; Epworth sleepiness scale ≥ 6; Polysomnography with respiratory disturbance index ≥ 10 hyponeic and/or apneic episodes per hour of sleep.
• Venous Stasis Disease – Presence or history of pretibial venous stasis ulcers.
• Chronic Joint Disease – Deterioration of joint cartilage and the formation of new bone (bone spurs) at the margins of the joints.
• Absence of current severe systemic disease (including, but not limited to: coronary artery disease, chronic obstructive pulmonary disease, congestive heart failure, cancer, and chronic renal disease).
• Agrees not to undergo any additional weight loss interventional procedures or liposuction for 12 months following study enrollment.
• Have not taken any prescription or over the counter weight loss medications OR those that can suppress appetite/induce weight loss for at least 6 months and agrees not to utilize for 12 months following study enrollment (including all stimulant medication).
• Subjects must be willing to possibly forego any future weight loss procedures (i.e., Vertical Sleeve Gastrectomy) given the unknown long-term effects.
• Residing within a reasonable distance from the Investigator’s treating office (~50 miles) and willing and able to travel to the Investigator’s office to complete all routine follow-up visits.
• Must be able to safely undergo non-contrasted MRI testing.

Exclusion Criteria: 

Exclusion criteria are the same as those of the main study on POSE2 safety and feasibility (IRB 19-001254), with the additional exclusion of patients who cannot safely undergo non-contrasted MRI.

• History of (or intra-operative evidence of) prior bariatric, gastric or esophageal surgery.
• Esophageal stricture or other anatomy and/or condition that could preclude passage of endoluminal instruments or procedure execution.
• Moderate gastro-esophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with drug therapy.
• Large hiatal hernia (> 3 cm) by history or as determined by pre-enrollment endoscopy.
• Pancreatic insufficiency/disease.
• History of gastroparesis or symptoms that would be suggestive of gastroparesis or generalized dysmotility (e.g., esophago-gastric motility issues and lower esophageal sphincter abnormalities).
• Pregnancy or plans of pregnancy in the next 12 months.
• History of a known diagnosis or pre-existing symptom of rheumatoid arthritis, scleroderma, system lupus, or other autoimmune connective tissue disorder.
• Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 6 months of Visit 1. Intranasal/inhaled steroids are acceptable.
• Unable or unwilling to avoid use of aspirin and/or non-steroidal anti-inflammatory drugs (NSAIDs), or other medications known to be gastric irritants beginning two weeks prior to enrollment and throughout the entire study.
• History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis.
• Active gastric erosion, lesion, or gastric/duodenal ulcer.
• History of or current platelet or coagulation dysfunction, such as hemophilia.
• History or present use of insulin or insulin derivatives for treatment of diabetes.
• Type II Diabetes Mellitus (as defined by HgbA1c >6.5%) for greater than 11 years at the time of enrollment.
• If smoker, plans to quit smoking in the year after enrollment.
• Portal hypertension and/or varices.
• Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.
• Present or history of psychosis, bipolar disease, or obsessive-compulsive disorder after pre-enrollment history and medical /psychological assessment.
• Beck Depression Inventory (Short) Score ≥ 12 and/or uncontrolled depression after pre-enrollment psychological and medical assessment. 1
• Patient score >2 in any of the 9 identified symptoms on the Gastroparesis Cardinal Symptom Index (GCSI).
• Patient with a 13C-Spirulina Gastric Emptying Breath Test (GEBT) result that is less than a kPCD/min of 34.4 at 120 minutes or 43 at 180 minutes.
• Non-ambulatory or has significant impairment of mobility (i.e., cannot ambulate for 30 minutes).
• Known hormonal or genetic cause for obesity including untreated hypothyroidism (TSH >5.0 U/ml).
• Participating in another clinical study.
• Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.
• Physician’s assessment that the subject is not an appropriate candidate.
• Subjects who are unable to safety undergo or who would not tolerate non-contrasted MRI.
• 1If significant findings for depression and/or suicidal ideation are identified, the psychologist(s) assigned to the study will be contacted and arrangement will be made for immediate intervention according to the Institution’s standard procedure.