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

Active, not recruiting

• Conditions: Morbid Obesity; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function; Diet and Nutrition - Obesity

• Registration Number: ACTRN12611000281998
• Lead Sponsor: Vibrynt, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

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).

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary end point of this study will be the six-month efficacy rate, as measured by average percentage excess weight loss (%EWL), for subjects treated with the PREVAIL Single Port Access Paragastric Implant System.[Six months following implantation]