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Trial registered on ANZCTR


Registration number
ACTRN12609000139279
Ethics application status
Approved
Date submitted
2/02/2009
Date registered
6/03/2009
Date last updated
7/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Percutaneous Single Port Access Placement of a Paragastric Implant for the Treatment of Morbid Obesity
Scientific title
Evaluation of Percutaneous Single Port Access Placement of a Paragastric Implant for the Treatment of Morbid Obesity
Secondary ID [1] 259790 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Morbid Obesity 4262 0
N/A 261377 0
Condition category
Condition code
Oral and Gastrointestinal 4487 4487 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A one-time, surgical procedure involving percutaneous, single-port access placement of a saline-filled silicone implant placed adjacent to the stomach and attached to the anterior abdominal wall. The implant is indicated for long-term implantation; however, it can be removed by means of a laparoscopic surgical procedure. Magnetic Resonance Imaging (MRI) procedures required prior to treatment, prior to discharge following treatment procedure, and at nine months post-implantation.
Intervention code [1] 3986 0
Treatment: Devices
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5368 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 patients treated with the Vibrynt Paragastric Implant System. %EWL is defined as weight loss divided by baseline excess weight: (baseline weight - post-surgery weight) / (baseline weight - ideal body weight).
Timepoint [1] 5368 0
Six months following implantation
Secondary outcome [1] 9021 0
Evaluation of the ability to successfully place the Paragastric Implant utilizing the Percutaneous Single Port Access technique.
Timepoint [1] 9021 0
Day 1 (procedure day)
Secondary outcome [2] 9022 0
Improvement in co-morbidities including: type 2 diabetes mellitus, hypertension, dyslipidemia, sleep apnea, coronary heart disease, osteoarthritis, and gall bladder disease. Co-morbidity improvements will be assessed by means of physical examination and clinical pathology.
Timepoint [2] 9022 0
Baseline and six months following implantation
Secondary outcome [3] 9023 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] 9023 0
Baseline and six months following implantation
Secondary outcome [4] 9024 0
Safety will be assessed by the incidence of severe or serious adverse events reported either by the patient 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] 9024 0
All events reported that occur anytime from day of procedure through six months following implantation

Eligibility
Key inclusion criteria
Patients 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 gallbladder disease).
Minimum age
18 Years
Maximum age
65 Years
Sex
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 patient a poor candidate for Paragastric Implant surgery; 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 sugery that would interfere with placement of the Paragastric Implant; non-ambulatory; acute or chronic infection (localized or systemic); history of cancer or life expectancy < 5 years; presence of any of the following medical conditions: inflammatory diseases of the 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
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
1/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
89
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4442 0
Commercial sector/Industry
Name [1] 4442 0
Vibrynt, Inc.
Country [1] 4442 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] 4002 0
None
Name [1] 4002 0
Address [1] 4002 0
Country [1] 4002 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6496 0
University of New South Wales HREC
Ethics committee address [1] 6496 0
Ethics committee country [1] 6496 0
Australia
Date submitted for ethics approval [1] 6496 0
01/10/2008
Approval date [1] 6496 0
10/03/2009
Ethics approval number [1] 6496 0
08245
Ethics committee name [2] 287136 0
John Flynn HREC
Ethics committee address [2] 287136 0
Ethics committee country [2] 287136 0
Australia
Date submitted for ethics approval [2] 287136 0
14/04/2009
Approval date [2] 287136 0
09/06/2009
Ethics approval number [2] 287136 0
08/07

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29242 0
Address 29242 0
Country 29242 0
Phone 29242 0
Fax 29242 0
Email 29242 0
Contact person for public queries
Name 12489 0
Rosalea Gunter
Address 12489 0
701 Galveston Drive
Redwood City, CA 94063
Country 12489 0
United States of America
Phone 12489 0
+11-650-362-6139
Fax 12489 0
+11-650-362-6182
Email 12489 0
rgunter@vibrynt.com
Contact person for scientific queries
Name 3417 0
Rosalea Gunter
Address 3417 0
701 Galveston Drive
Redwood City, CA 94063
Country 3417 0
United States of America
Phone 3417 0
+11-650-362-6139
Fax 3417 0
+11-650-362-6182
Email 3417 0
rgunter@vibrynt.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.