Continued Evaluation of Percutaneous Single Port Access Placement of a Paragastric Implant for the Treatment of Morbid Obesity

Vibrynt, Inc.0 个研究点目标入组 32 人开始时间: 2011年3月17日最近更新: 2020年1月13日

试验速览

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•Subjects who would otherwise qualify for bariatric surgery based on BMI and co-morbidity criteria put forth by the National Health and Medical Research Council (NHMRC) and the U.S. National Institutes of Health (NIH), and have presented to the Bariatric Clinic for consideration of weight loss surgery. These patients must have a Body Mass Index (BMI) >40 kg/m2 and35 kg/m2 and <40 kg/m2 with one or more significant medical conditions related to obesity (co-morbid conditions of type 2 diabetes, dyslipidemia, hypertension, obstructive sleep apnea, osteoarthritis, coronary heart disease, and gall bladder disease).

•Subject exhibits psychological or emotional characteristics which, in the opinion of the investigator, makes the subject a poor candidate for Paragastric Implant surgery
•Documented history of drug and/or alcohol addiction;
•women of childbearing potential who are not practicing an effective method of birth control or who are pregnant or lactating, or planning to become pregnant within 3 years;
•previous upper abdominal surgery that would interfere with placement of the Paragastric Implant; non-ambulatory;
•acute or chronic infection (localized or systemic);
•history of cancer or presence of terminal illness with life expectancy < 5 years;
•presence of any of the following medical conditions:
•Inflammatory diseases of the gastrointestinal (GI) tract, anomalies of the GI tract, upper GI bleeding conditions, esophageal or gastric disorders, severe cardiopulmonary disease, uncontrolled hypertension, portal hypertension, uncontrolled diabetes mellitus, cirrhosis of the liver, chronic pancreatitis, hiatal hernia, or immunocompromised.

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