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Trial registered on ANZCTR


Registration number
ACTRN12612000715875
Ethics application status
Not yet submitted
Date submitted
23/06/2012
Date registered
4/07/2012
Date last updated
4/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective Evaluation of Vibrynt’s Single Port Access Restrictive Therapy to Improve Life for the Morbidly Obese – United States Pivotal Study
Scientific title
A prospective, non-randomized, dual arm, 2:1 ratio, frequency matched trial to evaluate the effect of PREVAIL(Trademark) System vs.
REALIZE (Registered Trademark) Adjustable Gastric Band-C System on the percent excess weight loss at 2 years in morbidly obese patients.
Secondary ID [1] 280697 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Morbid Obesity 286734 0
Condition category
Condition code
Oral and Gastrointestinal 287033 287033 0 0
Normal oral and gastrointestinal development and function
Diet and Nutrition 287092 287092 0 0
Obesity
Surgery 287093 287093 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 285114 0
Treatment: Devices
Intervention code [2] 285158 0
Treatment: Surgery
Comparator / control treatment
REALIZE (Registered Trademark) Adjustable Gastric Band-C is a silicone implant laparoscopically placed for the surgical treatment of morbid obesity. The REALIZE Band is implanted using laparoscopic (minimally invasive) surgery. The gastric band is wrapped around the upper stomach to form an artificial stoma. This
placement creates a small pouch, or antechamber, in the proximal stomach and a larger pouch
in the distal stomach. After the gastric band is in place, the patient cannot consume large
quantities of food, and weight reduction ensues.
The average surgical procedure time is 75 minutes. The REALIZE Band is intended for long term use but may be removed laparoscopically if necessary.
Control group
Active

Outcomes
Primary outcome [1] 287368 0
Average percent excess weight loss (%EWL) with a 12% non-inferiority margin for participants treated with the PREVAIL System versus REALIZE Adjustable Gastric Band-C
%EWL defined as:
[(baseline weight minus post-surgery weight) / (baseline weight minus ideal body weight)]*100
Timepoint [1] 287368 0
2 years post-implantation
Secondary outcome [1] 298000 0
Device placement success rate (i.e., participant received an Implant)
Timepoint [1] 298000 0
Day 1 (procedure day)
Secondary outcome [2] 298001 0
Changes in Body Mass Index (BMI)
Timepoint [2] 298001 0
2 years post-implantation
Secondary outcome [3] 298002 0
Changes in waist to hip ratio
Timepoint [3] 298002 0
2 years post-implantation
Secondary outcome [4] 298003 0
Absolute weight loss (baseline weight-(follow-up weight-implant weight))
Timepoint [4] 298003 0
2 years post-implantation
Secondary outcome [5] 298004 0
The percentage of the study population achieving a 25% EWL will be determined, with a responder rate of greater than or equal to 50% required.
Timepoint [5] 298004 0
2 years post-implantation
Secondary outcome [6] 298005 0
Decrease in comorbidities (diabetes, hypertension, dyslipidemia) as measured by changes in HbA1c, HDL, LDL, total cholesterol, triglycerides, and fasting plasma glucose
Timepoint [6] 298005 0
2 years post-implantation
Secondary outcome [7] 298006 0
Changes in quality of life measures
Suter Quality of Alimentation Survey
Three Factor Eating Questionnaire R-18 [TFEQ]
SF-36
Beck Depression Inventory-II [BDI-II])
Timepoint [7] 298006 0
2 years post-implantation
Secondary outcome [8] 298007 0
Incidence (including severity and seriousness) of device-related adverse events. Adverse events are defined as:undesirable clinical occurrence or untoward deviation in health away from baseline
Adverse event severity will be categorized into 3 defined categories: mild, moderate and severe and are defined in the protocol. Seriousness will be assessed according to the ISO14155 and protocol definitions of seriousness.
Timepoint [8] 298007 0
2 years post-implantation
Secondary outcome [9] 298058 0
Incidence (including severity and seriousness) of all adverse events. Adverse events are defined as: undesirable clinical occurrence or untoward deviation in health away from baseline
Adverse event severity will be categorized into 3 defined categories: mild, moderate and severe and are defined in the protocol. Seriousness will be assessed according to the ISO14155 and protocol definitions of seriousness.
Timepoint [9] 298058 0
2 years post-implantation
Secondary outcome [10] 298059 0
Post-PMA (Pre- Market Approval Application) submission, incidence (including severity and seriousness) of device-related adverse events.
Examples of device related adverse events: abdominal pain, infection).
Investigator at each investigational site is responsible for reporting all adverse events (including determining severity and relatedness to the device and procedure).
Timepoint [10] 298059 0
years 3 to 5 post implantation

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
543
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 4369 0
United States of America
State/province [1] 4369 0
Country [2] 4370 0
United Kingdom
State/province [2] 4370 0

Funding & Sponsors
Funding source category [1] 285464 0
Commercial sector/Industry
Name [1] 285464 0
Vibrynt, Inc.
Country [1] 285464 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] 284318 0
Commercial sector/Industry
Name [1] 284318 0
Emergo Australia
Address [1] 284318 0
201 Sussex Street
Darling Park, Tower II, Level 20
Sydney, NSW 2000 Australia
Country [1] 284318 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287478 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 287478 0
Ethics committee country [1] 287478 0
Australia
Date submitted for ethics approval [1] 287478 0
20/06/2012
Approval date [1] 287478 0
Ethics approval number [1] 287478 0

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

Contacts
Principal investigator
Name 34333 0
Address 34333 0
Country 34333 0
Phone 34333 0
Fax 34333 0
Email 34333 0
Contact person for public queries
Name 17580 0
Kristen Honl, VP Clinical Affairs, Regulatory Affairs and Quality Assurance
Address 17580 0
701 Galveston Drive
Redwood City, CA 94063
Country 17580 0
United States of America
Phone 17580 0
+1 650-362-6119
Fax 17580 0
Email 17580 0
khonl@vibrynt.com
Contact person for scientific queries
Name 8508 0
Kristen Honl, VP Clinical Affairs, Regulatory Affairs and Quality Assurance
Address 8508 0
701 Galveston Drive
Redwood City, CA 94063
Country 8508 0
United States of America
Phone 8508 0
+1 650-362-6119
Fax 8508 0
Email 8508 0
khonl@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.