None listed
Conditions
Brief summary
The PREVAIL (Trademark) Single Port Access Paragastric Implant System is a novel approach to the treatment of morbid obesity. The saline-filled Paragastric Implant is placed in a minimally invasive fashion into the abdominal cavity in the space adjacent the stomach, thereby reducing the ability of the stomach to expand and reducing oral intake. The Paragastric Implant volume can be adjusted by the addition or removal of sterile saline through a subcutaneous port. This trial is a single-arm, prospective, multi-center study designed to demonstrate the safety and effectiveness of the Vibrynt PREVAIL (Trademark) Paragastric Implant System in the treatment of morbid obesity. The primary end point of this study will be the six-month efficacy rate, as measured by the average percent excess weight loss for subjects treated with the PREVAIL(Trademark) Single Port Access Paragastric Implant System . Subjects will be followed for three years for long term safety and efficacy evaluations.
Interventions
A one-time surgical procedure involving percutaneous, single-port access placement of the PREVAIL(Trademark) Single Port Access Paragastric Implant System. A saline filled silicone implant placed adjacent to the stomach and attached to the anterior abdominal wall. The approximate duration of the procedure is 30-60 minutes. The implant is indicated for long-term implantation; however, it can be removed by means of a laparoscopic surgical procedure.
Sponsors
Vibrynt, Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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 and</= 50 kg/m2, or >35 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.
Outcome results
None listed