Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00555958




Registration number
NCT00555958
Ethics application status
Date submitted
8/11/2007
Date registered
9/11/2007
Date last updated
2/02/2012

Titles & IDs
Public title
Vagal Blocking for Obesity Control
Scientific title
VBLOC™ Clinical Trial: Vagal Block for Obesity Control
Secondary ID [1] 0 0
D00292-000
Secondary ID [2] 0 0
VBLOC
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Active, implantable, intra-abdominal vagal blocking medical device

Experimental: A - All study subjects will be implanted with the Maestro System, and all will receive VBLOC therapy.


Treatment: Devices: Active, implantable, intra-abdominal vagal blocking medical device
Intermittent, programmable, intra-abdominal vagal blocking
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Excess weight loss (EWL)
Timepoint [1] 0 0
4 and 12 weeks, and 6, 12, 24, 36, 48 and 60 months
Primary outcome [2] 0 0
Serious Adverse Events (SAE) and Unanticipated Adverse Device Effects (UADE)
Timepoint [2] 0 0
4 and 12 weeks, and 6, 12, 24, 36, 48 and 60 months

Eligibility
Key inclusion criteria
* Body mass index (BMI) 35-50 +/- 10% inclusive
* Failure to respond to diet/exercise program
Minimum age
25 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of gastric resection or major upper-abdominal surgery (e.g. cholycystectomy, hysterectomy acceptable)
* Current type 1 diabetes mellitus (DM) or poorly controlled type 2 DM
* Reductions of more than 10% of body weight in the previous 12 months
* Current medical condition that would make subject unfit for surgery under general anesthesia or that would be exacerbated by intentional weight loss

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
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2014
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Institute of Weight Control - Sydney
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
2153 - Sydney
Recruitment outside Australia
Country [1] 0 0
Mexico
State/province [1] 0 0
Mexico City
Country [2] 0 0
Norway
State/province [2] 0 0
Trondheim
Country [3] 0 0
Switzerland
State/province [3] 0 0
Basel

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ReShape Lifesciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To determine the safety, efficacy and treatment algorithm(s) of the Maestro System in causing weight loss in obese subjects - This study will provide feasibility data regarding the potential of intra-abdominal vagus nerve down-regulation/block in the treatment of obesity.
Trial website
https://clinicaltrials.gov/study/NCT00555958
Trial related presentations / publications
Shikora S, Toouli J, Herrera MF, Kulseng B, Zulewski H, Brancatisano R, Kow L, Pantoja JP, Johnsen G, Brancatisano A, Tweden KS, Knudson MB, Billington CJ. Vagal blocking improves glycemic control and elevated blood pressure in obese subjects with type 2 diabetes mellitus. J Obes. 2013;2013:245683. doi: 10.1155/2013/245683. Epub 2013 Jul 30.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00555958