ObesityNCT00555958
Vagal Blocking for Obesity Control
A study testing Active, implantable, intra-abdominal vagal blocking medical device in people with Obesity, run by ReShape Lifesciences at 5 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Active, implantable, intra-abdominal vagal blocking medical device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Nov 2005to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index (BMI) 35-50 +/- 10% inclusive
- Failure to respond to diet/exercise program
Who cannot join
- 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
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Australia2 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
Institute of Weight Control
Sydney, 2153
Mexico1 site
Instituto Nacional de la Nutrición Salvador Zubiran (INNSZ)
Mexico City, 14000
Norway1 site
National Center for Advanced Laparoscopic Surgery, St. Olavs University Hospital
Trondheim, 7489
Switzerland1 site
University Hospital Basel, Department of Internal Medicine
Basel, 4031
About this study
Official title: VBLOC™ Clinical Trial: Vagal Block for Obesity Control
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.
Read the detailed description
The development of innovative, safe and effective therapeutic options for the treatment of obese patients is both desirable and necessary. Gastric bypass operations are usually effective both short- and long-term but are also not available to or desired by many obese people for a variety of reasons. Gastric banding procedures are also available but have been reported to be less effective than gastric bypass operations. Diets, exercise programs and pharmaceutical agents offer short-term effectiveness for some obese patients but are all too often ineffective in the long term. The ever increasing impact of obesity on morbidity, mortality and accelerating healthcare resource utilization in most developed countries is well documented.
Activation and up-regulation of the efferent and afferent fibers of the intra-abdominal vagal nerve trunks is a pivotal physiological mechanism for food ingestion, mechanical processing, enzymatic digestion and calorie absorption. EnteroMedics' Maestro™ System is designed to take therapeutic benefit from these physiological principles by reversibly and controllably down-regulating/blocking both the anterior and posterior intra-abdominal vagal trunks in order to: (1) reduce food intake by reducing gastric volume; (2) initiate early and prolonged satiation by delaying gastric emptying; and, (3) decrease calorie absorption by down-regulating pancreatic exocrine secretion and digestion. This multi-modal mechanism is implemented in order achieve predictable and controllable loss of body weight.
This is a prospective, open-label, multi-center, clinical trial with the subjects' baseline parameters as the control. Subjects implanted laparoscopically with the Maestro System were followed from 6-months to two years.
- Implantable components: two flexible leads (including one electrode each for the anterior and posterior intra-abdominal vagal nerve trunks) that are connected to an implantable neuroregulator placed subcutaneously on the abdominal wall below the costal margin (a minimum of two or three finger widths below), or a location determined by the surgeon and consistent with device operation.
- External components:
- For the Maestro System using a neuroregulator with an internal rechargeable battery: one mobile charger for the implanted neuroregulator, which is connected via a small, flexible cable to a cutaneous transmit coil that is positioned over the implanted neuroregulator when charging the device or determining the status of the device; a software program on a laptop computer that transmits information to the neuroregulator and uploads data from the neuroregulator, which is available to the clinician, allowing both change in treatment regimens and assessment of treatment compliance.
- For the Maestro System using a neuroregulator with no battery: one programmable, battery-powered ambulatory controller connected via a small, flexible cable to a cutaneous transmit coil that is positioned over the implanted neuroregulator to provide power for the device; a software program on a laptop computer that transmits information to and uploads data from the controller which is available to the clinician, allowing both change in treatment regimens and assessment of treatment compliance.
The objectives of this trial are as follows:
- Determination of efficacy by quantification of excess body weight loss (EWL) at 4 and 12 weeks, and 6, 12, 24, 36, 48 and 60 months.
- Evaluation of safety through 4 and 12 weeks, and 6, 12, 24, 36, 48 and 60 months.
- Selection of effective daily treatment regimen(s).
- Conditions
- Obesity
- Being tested
- Active, implantable, intra-abdominal vagal blocking medical device
- Keywords
- Obesity, Bariatric surgery, Excess weight loss, Vagus nerve, Vagal blocking, VBLOC(TM) therapy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active, implantable, intra-abdominal vagal blocking medical deviceDevice
Intermittent, programmable, intra-abdominal vagal blocking
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | All study subjects will be implanted with the Maestro System, and all will receive VBLOC therapy. Receives: Device: Active, implantable, intra-abdominal vagal blocking medical device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excess weight loss (EWL)
Measured: 4 and 12 weeks, and 6, 12, 24, 36, 48 and 60 months
Serious Adverse Events (SAE) and Unanticipated Adverse Device Effects (UADE)
Measured: 4 and 12 weeks, and 6, 12, 24, 36, 48 and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startNov 2005
- Primary completionSep 2011
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReShape Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555958
- Sponsor's protocol ID
- VBLOC
- Other IDs
- D00292-000
- Status last verified
- Feb 2012
- First submitted
- 8 Nov 2007
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 23984050
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VBLOC™ Clinical Trial: Vagal Block for Obesity Control
- ClinicalTrials.gov ID
- NCT00555958
- Acronym / sponsor ID
- VBLOC
- Conditions
- Obesity
- Keywords
- Obesity, Bariatric surgery, Excess weight loss, Vagus nerve, Vagal blocking, VBLOC(TM) therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- ReShape LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2014 (estimated)
- First posted
- 9 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The development of innovative, safe and effective therapeutic options for the treatment of obese patients is both desirable and necessary. Gastric bypass operations are usually effective both short- and long-term but are also not available to or desired by many obese people for a variety of reasons. Gastric banding procedures are also available but have been reported to be less effective than gastric bypass operations. Diets, exercise programs and pharmaceutical agents offer short-term effectiveness for some obese patients but are all too often ineffective in the long term. The ever increasing impact of obesity on morbidity, mortality and accelerating healthcare resource utilization in most developed countries is well documented.
Activation and up-regulation of the efferent and afferent fibers of the intra-abdominal vagal nerve trunks is a pivotal physiological mechanism for food ingestion, mechanical processing, enzymatic digestion and calorie absorption. EnteroMedics' Maestro™ System is designed to take therapeutic benefit from these physiological principles by reversibly and controllably down-regulating/blocking both the anterior and posterior intra-abdominal vagal trunks in order to: (1) reduce food intake by reducing gastric volume; (2) initiate early and prolonged satiation by delaying gastric emptying; and, (3) decrease calorie absorption by down-regulating pancreatic exocrine secretion and digestion. This multi-modal mechanism is implemented in order achieve predictable and controllable loss of body weight.
This is a prospective, open-label, multi-center, clinical trial with the subjects' baseline parameters as the control. Subjects implanted laparoscopically with the Maestro System were followed from 6-months to two years.
- Implantable components: two flexible leads (including one electrode each for the anterior and posterior intra-abdominal vagal nerve trunks) that are connected to an implantable neuroregulator placed subcutaneously on the abdominal wall below the costal margin (a minimum of two or three finger widths below), or a location determined by the surgeon and consistent with device operation.
- External components:
- For the Maestro System using a neuroregulator with an internal rechargeable battery: one mobile charger for the implanted neuroregulator, which is connected via a small, flexible cable to a cutaneous transmit coil that is positioned over the implanted neuroregulator when charging the device or determining the status of the device; a software program on a laptop computer that transmits information to the neuroregulator and uploads data from the neuroregulator, which is available to the clinician, allowing both change in treatment regimens and assessment of treatment compliance.
- For the Maestro System using a neuroregulator with no battery: one programmable, battery-powered ambulatory controller connected via a small, flexible cable to a cutaneous transmit coil that is positioned over the implanted neuroregulator to provide power for the device; a software program on a laptop computer that transmits information to and uploads data from the controller which is available to the clinician, allowing both change in treatment regimens and assessment of treatment compliance.
The objectives of this trial are as follows:
- Determination of efficacy by quantification of excess body weight loss (EWL) at 4 and 12 weeks, and 6, 12, 24, 36, 48 and 60 months.
- Evaluation of safety through 4 and 12 weeks, and 6, 12, 24, 36, 48 and 60 months.
- Selection of effective daily treatment regimen(s).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Active, implantable, intra-abdominal vagal blocking medical deviceAll study subjects will be implanted with the Maestro System, and all will receive VBLOC therapy. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) 35-50 +/- 10% inclusive
- Failure to respond to diet/exercise program
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active, implantable, intra-abdominal vagal blocking medical deviceIntermittent, programmable, intra-abdominal vagal blocking | Device | A |
Primary outcome
Excess weight loss (EWL)
Time frame: 4 and 12 weeks, and 6, 12, 24, 36, 48 and 60 months
Serious Adverse Events (SAE) and Unanticipated Adverse Device Effects (UADE)
Time frame: 4 and 12 weeks, and 6, 12, 24, 36, 48 and 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2012.
- Derived from this study: PubMed 23984050Shikora 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active, implantable, intra-abdominal vagal blocking medical device in people with Obesity, run by ReShape Lifesciences at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, Mexico, Norway, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excess weight loss (EWL) (time frame: 4 and 12 weeks, and 6, 12, 24, 36, 48 and 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00555958, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2012.