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Trial registered on ANZCTR


Registration number
ACTRN12611000281998
Ethics application status
Approved
Date submitted
16/03/2011
Date registered
17/03/2011
Date last updated
17/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Continued Evaluation of Percutaneous Single Port Access Placement of a Paragastric Implant for the Treatment of Morbid Obesity
Scientific title
Continued Evaluation of Percutaneous Single Port Access Placement of a Paragastric Implant for the Treatment of Morbid Obesity
Secondary ID [1] 259788 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Morbid Obesity 261375 0
Condition category
Condition code
Oral and Gastrointestinal 259530 259530 0 0
Normal oral and gastrointestinal development and function
Diet and Nutrition 259541 259541 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 264225 0
Treatment: Devices
Intervention code [2] 264234 0
Treatment: Surgery
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262338 0
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.
Timepoint [1] 262338 0
Six months following implantation
Secondary outcome [1] 273567 0
Evaluation of the ability to successfully place the Paragastric Implant utilizing the Percutaneous Single Port Access technique. This outcome will be assessed by the successful deployment into the abdominal cavity, attachment to the anterior abdominal wall and inflation of the implant.
Timepoint [1] 273567 0
Day 1 (procedure day)
Secondary outcome [2] 273568 0
Improvement in co-morbidities including:
Type II diabetes mellitis, hypertension, dislipidemia, sleep apnea, coronary heart disease, osteoarthritis, and gall bladder disease. Improvements will be assessed by means of physical examination and clinical pathology.
Timepoint [2] 273568 0
Baseline and six months following implantation
Secondary outcome [3] 273569 0
Improvement in quality of life measures, as assessed using the following questionnaires:
Three Factor Eating Questionnaire
Beck Depression Inventory
Short Form 36 (SF-36)
Short Musculoskeletal Function Assessment
Timepoint [3] 273569 0
Baseline and six months following implantation
Secondary outcome [4] 273570 0
Safety will be assessed by the incidence of severe or serious adverse events reported either by the subject or observed by the investigator, relating to the procedure or to the device itself either peri-operatively or in the follow-up period.
Timepoint [4] 273570 0
All events reported that occur anytime from day of procedure through six months following implantation.

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264672 0
Commercial sector/Industry
Name [1] 264672 0
Vibrynt, Inc.
Address [1] 264672 0
701 Galveston Drive
Redwood City, CA 94063
Country [1] 264672 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Vibrynt, Inc.
Address
701 Galveston Drive
Redwood City, CA 94063
Country
United States of America
Secondary sponsor category [1] 263806 0
None
Name [1] 263806 0
Address [1] 263806 0
Country [1] 263806 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266665 0
University of New South Wales HREC
Ethics committee address [1] 266665 0
UNSW Grants Management Office
Rupert Myers Building
University of NSW
Randwick, NSW 2052
Ethics committee country [1] 266665 0
Australia
Date submitted for ethics approval [1] 266665 0
01/03/2011
Approval date [1] 266665 0
17/06/2011
Ethics approval number [1] 266665 0
08245
Ethics committee name [2] 266666 0
Bellberry Human Research Ethics Committee
Ethics committee address [2] 266666 0
229 Greenhill Road
Dulwich
South Australia 5065
Ethics committee country [2] 266666 0
Australia
Date submitted for ethics approval [2] 266666 0
30/03/2011
Approval date [2] 266666 0
27/04/2011
Ethics approval number [2] 266666 0
2011-03-139

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32347 0
Address 32347 0
Country 32347 0
Phone 32347 0
Fax 32347 0
Email 32347 0
Contact person for public queries
Name 15594 0
Rosalea Gunter
Address 15594 0
701 Galveston Drive
Redwood City, CA 94063
Country 15594 0
United States of America
Phone 15594 0
+11-650-362-6139
Fax 15594 0
+11-650-362-6182
Email 15594 0
rgunter@vibrynt.com
Contact person for scientific queries
Name 6522 0
Rosalea Gunter
Address 6522 0
701 Galveston Drive
Redwood City, CA 94063
Country 6522 0
United States of America
Phone 6522 0
+11-650-362-6139
Fax 6522 0
+11-650-362-6182
Email 6522 0
rgunter@vibrynt.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary