None listed
Conditions
Brief summary
To evaluate the safety and effectivness of the VIBRYNT PREVAIL Paragastric Implant System for the treatment of morbid obesity. Efficacy will be demonstrated if the average percent excess weight loss (%EWL) among those participants implanted with the PREVAIL System is found to be not inferior to the %EWL observed amoung participants implanted with the REALIZE Adjustable Gastric Band-C.
Interventions
The PREVAIL (Trademark) System involves laparoscopic placement of the PREVAIL Implant (a saline filled silicone implant), into the abdominal cavity with a size, shape, and orientation that inhibits typical stomach expansion that occurs with eating. The PREVAIL implant is secure to the anterior abdominal wall. The PREVAIL Implant is designed to occupy the space the stomach would normally expand into when filled with food. This is done without any modification to the stomach or surrounding anat
The PREVAIL (Trademark) System involves laparoscopic placement of the PREVAIL Implant (a saline filled silicone implant), into the abdominal cavity with a size, shape, and orientation that inhibits typical stomach expansion that occurs with eating. The PREVAIL implant is secure to the anterior abdominal wall. The PREVAIL Implant is designed to occupy the space the stomach would normally expand into when filled with food. This is done without any modification to the stomach or surrounding anatomy. The approximate duration of the surgery is 35-60 minutes. The implant is indicated for long term implantation. The maximum duration the PREVAIL Implant may remain in place is 40 years; however, it can be removed by means of a laparoscopic surgical procedure.
Sponsors
Vibrynt, Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Body Mass Index (BMI) greater than or equal to 40 kg/m2 and less than or equal to 50 kg/m2, or greater than or equal to 35 kg/m2 and less than 40 kg/m2 with one or more significant medical conditions related to obesity (comorbid conditions of Type 2 diabetes, dyslipidemia, hypertension, osteoarthritis, obstructive sleep apnea, coronary heart disease, and gallbladder disease) 5 year history of morbid obesity Documented failure with non-surgical, weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs Able to comprehend, follow, and give signed informed consent Willing to commit to significant lifestyle changes that include diet, eating, and exercise habits for the duration of the clinical trial Able to commit to long-term follow-up up to 5 years after device implantation, including implant adjustment visits An absence of significant psychopathology that could have limited the participant’s ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations, as documented during screening assessment Family or other strong social support network in place Able to commit to the financial requirements of the $2000 study copayment. Living within a one hour commute to clinical site (needed for follow up visits) Participant’s ability to understand and describe the actions, eating behaviors and lifestyle that resulted in their current weight and are accountable for or have contributed to their current health Agree to refrain, for five years following implant placement, from any type of cosmetic or reconstructive surgery (such as abdominal lipoplasty or liposuction, mammoplasty, or removal of excess skin) that will affect body weight Agree to refrain from taking any weight loss medications for the five year duration of the study Women of childbearing potential agree to practice an effective method of birth control for the five year duration of the study Type 2 diabetes mellitus participants that are well-controlled (limited to approximately 30 participants)
Exclusion criteria
History of deep vein thrombosis (DVT) or other known hypercoagulability condition within the previous year Exhibits psychological, emotional, or behavioral characteristics which, in the opinion of the investigator, makes the participant a poor candidate for Paragastric Implant or Gastric Band surgery Current diagnosis of severe depression Documented history of drug and/or alcohol abuse within two years prior to the Screening Visit 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 5 years Previous open abdominal surgery, or any other previous surgical procedure, or an abdominal trauma such as a car accident or fall that could interfere with placement of the Vibrynt Implant Presence of an umbilical hernia that is irreducible, symptomatic, or greater than 2 cm Acute or chronic infection (localized or systemic) Current diagnosis of cancer, renal failure, heart failure, or has a terminal illness with life expectancy < 5 years Presence of any of the following medical conditions: Inflammatory diseases of the gastrointestinal (GI) tract, including severe intractable esophagitis, gastric ulceration, duodenal ulceration, or specific inflammation such as Crohn’s disease or ulcerative colitis that has been active within the past 10 years. Mild gastritis or mild gastric erosion may be treated and the participant included at the discretion of the Site Principal Investigator. Congenital or acquired anomalies of the GI tract, including atresias or stenosis Hepatomegaly, splenomegaly, or other organomegaly that interferes with implant placement Severe cardiopulmonary disease (including heart failure), renal disease or other serious organic disease that may make the participant a poor surgical candidate Uncontrolled hypertension in spite of therapy Portal hypertension Uncontrolled diabetes mellitus in spite of therapy Chronic or acute upper GI bleeding conditions, e.g., gastric or esophageal varices Cirrhosis of the liver Chronic pancreatitis Esophageal or gastric disorders including severe preoperative reflux, achalasia, dysmotility, dysphagia, or Barrett’s esophagus Presence of a hiatal hernia > 2 cm (0.78 in). Hernias under this size may be repaired at the surgeon’s discretion prior to the implantation procedure per standard of care Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders Conditions that, in the opinion of the investigator, present an unreasonable risk to the participant. Note that certain conditions may only be noted intraoperatively (e.g., significant adhesions, hiatal hernia). If the condition is found intraoperatively, the participant shall be considered a surgical screen failure. Use of prescription or over-the-counter weight reduction medictions or supplements within one month prior to the Screening Visit and for the five year duration of the study. Known or suspected allergy to silicone or other materials contained in the Paragastric Implant and Injection Port History of intolerance of implanted devices Not ambulatory History of chronic pain Participation in another clinical trial within 8 weeks of the Screening Visit and for the duration of this trial. Affiliated with the study site personnel (e.g., the investigators, sub-investigators or study coordinators) or their relatives. Candidates excluded from undergoing other bariatric surgical procedures for health reasons Participants with chest dimensions that are outside of the range of specifications for the Paragastric Implant sizes Type 2 diabetic participants with any of the following conditions: Are on injectable insulin or other injectable therapies such as a Glucagon-like peptide analogue (e.g., exenatide) or Amylin (Symlin), or have not ceased such medications at least two weeks prior to device implantation Were diagnosed > five years prior to Screening Visit Are refractory to insulin therapy (insulin dose >2 units/kg body weight/day) Have a HbA1c > 9.5%, or fasting plasma glucose >180 mg/dL Or who are experiencing severe and progressing diabetic complications (e.g., retinopathy, neuropathy, or nephropathy with macroalbuminuria) Or who have history of severe hypoglycemia during the past 6 months
Outcome results
None listed