ObesityEMPOWERNCT00521079
EMPOWER Clinical Trial: Vagal Blocking for Obesity Control
A study testing Therapy ON and Therapy OFF in people with Obesity, run by ReShape Lifesciences at 15 sites in 2 countries.
Trial summary
This is a randomized multi-center study being done to measure the ability of a new medical device, Maestro System, to safely reduce body weight over five years in people who are considered obese. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Therapy ON and Therapy OFF
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Aug 2007to May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent.
- Body mass index (BMI) ≥ 40 kg/m2 to 45 kg/m2 or BMI ≥ 35 kg/m2 to 39.9 kg/m2 with one or more obesity related co-morbid condition. Co-morbid conditions may include one or more of the following:
- Type 2 diabetes mellitus (note: type 2 diabetics are allowed at selected centers only, see Inclusion criterion #5)
- Hypertension as defined by systolic pressure ≥140 mmHg and/or diastolic pressure ≥90 mmHg a) treated or untreated with systolic ≥140 mmHg or diastolic ≥90 mmHg or b) treated with systolic <140 mmHg and diastolic <90 mmHg
- Dyslipidemia as defined by total cholesterol ≥200 or LDL ≥130 a) treated or untreated with total cholesterol ≥200 or LDL ≥130 or b) treated with total cholesterol <200 or LDL <130
- Sleep apnea syndrome (confirmed by overnight p02 studies)
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- Obesity related cardiomyopathy
- Females or males Note: females of child-bearing potential must have a negative urine pregnancy test at Screen and also within 14 days of implant procedure followed by physician-approved contraceptive regimen for the duration of the study period.
- 18-65 years of age inclusive.
- Type 2 diabetes mellitus subjects (at selected centers, limited to approximately 34 subjects) with:
- Glycosylated hemoglobin (Hb A1c) 6.5 - 9 % inclusive at screening visit.
- Onset: 10 years or less since initial diagnosis.
- Stable treatment regimen: no change in oral hypoglycemic treatment regimen within past 3 months.
- Currently not using insulin therapy, GLP-1 receptor agonists (e.g., exenatide), or DPP-4 inhibitors (e.g., sitagliptin) for diabetes treatment and have not been on these treatments in the past 6 months.
- Creatinine within normal reference range.
- No history of proliferative retinopathy.
- No history of peripheral neuropathy.
- No history of autonomic neuropathy.
- No history of coronary artery disease, with or without angina pectoris.
- No history of peripheral vascular disease.
- Failure to respond to supervised diet/exercise program(s) in which the subject was engaged for at least 6 months within the last five years.
- Ability to complete all study visits and procedures.
Who cannot join
- Concurrent chronic pancreatic disease.
- History of Crohn's disease and/or ulcerative colitis.
- History of bariatric surgery, fundoplication, gastric resection or major upper-abdominal surgery (acceptable surgeries include cholecystectomy, hysterectomy).
- History of pulmonary embolism or blood coagulation disorders.
- Clinically significant hiatal hernias known from subject's medical record as or determined by upper endoscopy prior to implant if they have not had one done during the previous 6 months that specifically reported on the presence or absence of hiatal hernia making reference to the Z-line and/or diaphragmatic notch, in order to rule out subjects with hiatal hernia that may require surgical repair (to support exclusion criterion #7).
- Current portal hypertension and/or esophageal varices.
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- Intra-operative exclusion: hiatal hernia requiring surgical repair or extensive dissection at esophagogastric junction at time of surgery.
- Treatment with weight-loss prescription drug therapy within the prior three months and the use of prescription drug therapy or the use over-the-counter weight loss preparations for the duration of the trial.
- Smoking cessation within the prior six months.
- Known genetic cause of obesity (e.g., Prader-Willi Syndrome).
- Overall sustained reduction of more than 10% of body weight in the previous 12 months.
- Physician-prescribed pre-operative diet with intent to lose weight prior to surgery (note: a) study subject may continue any personal diet they were on prior to study enrollment [see exclusion criterion #24] b) standardized EMPOWER weight management program to be initiated in all subjects at time of activation, approximately two weeks after implant)
- Current type 1 diabetes mellitus (DM).
- Current or recent history (within 12 months) of ongoing bulimia.
- Current alterations in treatment for thyroid disorders (stable treatment regimen for prior three months acceptable).
- Current alterations in treatment for epilepsy (stable treatment regimen for prior six months acceptable).
- Current treatment for peptic ulcer disease (previous history acceptable).
- Chronic (more than 4 weeks of daily use) treatment with narcotic analgesic drug regimens (treatment with non-steroidal anti-inflammatory drugs acceptable).
- Current alterations in treatment regimens of anti-cholinergic drugs, including tricyclic antidepressants (stable treatment regimen for prior six months acceptable).
- Current medical condition that, in the opinion of the investigator, would make subject unfit for surgery under general anesthesia or that would be exacerbated by intentional weight loss. Some examples include diagnosis of cancer, recent heart attack, recent stroke or recent serious trauma.
- Presence of permanently implanted electrical powered medical device or implanted gastrointestinal device or prosthesis (e.g., pacemakers, implanted defibrillators, neurostimulators etc.).
- Planned or contemplated use of Magnetic Resonance Imaging (MRI) or oncological radiation during the course of the trial.
- Significant psychiatric disorders that, in the opinion of the investigator, may interfere with subject's ability to follow study procedures and/or instructions.
- Current, active member of an organized weight loss program (e.g., Weight Watchers, TOPS).
- Current participant in another weight loss study or other clinical trials.
- Have a friend or family member who is currently participating or is planning to participate in this clinical trial.
- Patient reported:
- inability to walk for about 10 minutes without stopping,
- feeling of pain in chest when doing physical activity,
- feeling of pain in chest when not doing physical activity. Note: unless pain in chest in known to be related to upper gastrointestinal disorders such as gastroesophageal reflux disease or heartburn.
- Clinically significant cardiac rhythm disorder that requires either medical and/or surgical intervention (e.g., paroxysmal or chronic atrial fibrillation).
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States13 sites
Johns Hopkins
Baltimore, Maryland, 21224
Tufts New England Medical Center
Boston, Massachusetts, 02111
Cleveland Clinic - Ohio
Cleveland, Ohio, 44195
Scripps Clinic
La Jolla, California, 92037
University of Minnesota
Minneapolis, Minnesota, 55455
University of California, Irvine Medical Center
Orange, California, 92868
Oregon Health & Science University
Portland, Oregon, 97239-3098
Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
HonorHealth (formerly Scottsdale Bariatric Center)
Scottsdale, Arizona, 85258
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford University Medical Center
Stanford, California, 94305
Cleveland Clinic - Florida
Weston, Florida, 33331
Australia2 sites
Adelaide Bariatric Center - Flinders Private Hospital
Bedford Park, South Australia, 5042
Institute of Weight Control
Sydney, New South Wales, 2153
About this study
This is a randomized multi-center study being done to measure the ability of a new medical device, Maestro System, to safely reduce body weight over five years in people who are considered obese.
Read the detailed description
The Maestro System is a neuromodulation system that consists of implantable and external components.
Implantable components: two leads (one electrode each for the anterior and posterior intra-abdominal vagal nerve trunks) that are connected to an implantable neuroregulator.
External components: one programmable, battery-powered, ambulatory external controller connected via a small, flexible cable to a cutaneous transmit coil that is positioned externally over the neuroregulator. A clinician programmer that transmits information to the controller and uploads data from the controller.
All non-diabetic subjects will be randomized in a 2:1 allocation to therapy ON or therapy OFF groups. All type 2 diabetes mellitus subjects will be randomized in a 1:1 allocation to therapy ON or therapy OFF groups.
All subjects will receive blinded therapy through the 12-month follow-up visit. All subjects will participate in a medical weight management program.
- Conditions
- Obesity
- Being tested
- Therapy ON, Therapy OFF
- 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.
Therapy ONDevice
Also called Maestro System
Intermittent, programmable, intra-abdominal vagal blocking device that delivers therapy (Therapy ON)
Therapy OFFDevice
Also called Maestro System
Active intra-abdominal placebo device that delivers no therapy (Therapy OFF)
| Study group | Role | What they receive |
|---|---|---|
| vBloc | Experimental | Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON). Receives: Device: Therapy ON |
| Placebo | Sham comparator | Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF). Receives: Device: Therapy OFF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Excess Weight Loss (EWL) With the Maestro System
Observe at least a 10% greater percentage excess weight loss (%EWL) with vBloc therapy delivered by the Maestro System compared to sham 12 months following randomization using MetLife Method (ideal body weight is calculated based on Metropolitan Height and Weight Tables)
Measured: Baseline and 1 Year
Rate of System and Procedure-related Serious Adverse Events (SAEs).
To estimate the rate of serious, system- and procedure-related adverse events associated with the Maestro System.
Measured: 1 Year
Secondary outcomes (1)
Percentage of Participants Achieving 25% Excess Weight Loss (%EWL)
To evaluate the percentage of participants achieving 25% excess weight loss from baseline (implant) to 12 months between treatment groups.
Measured: Baseline and 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionOct 2009
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- ReShape Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles J Billington, MD, Principal investigator, VA Medical Center, Minneapolis, MN / University of MinnesotaMichael Sarr, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521079
- Sponsor's protocol ID
- D00343-000
- Acronym
- EMPOWER
- Status last verified
- May 2018
- First submitted
- 23 Aug 2007
- Last updated
- 24 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMPOWER Clinical Trial: Vagal Blocking for Obesity Control
- ClinicalTrials.gov ID
- NCT00521079
- Acronym / sponsor ID
- EMPOWER / D00343-000
- Conditions
- Obesity
- Keywords
- Obesity, Bariatric surgery, Excess weight loss, Vagus nerve, Vagal blocking, vBloc(TM) therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- ReShape LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 27 Aug 2007 (estimated)
- Results
- Posted 20 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized multi-center study being done to measure the ability of a new medical device, Maestro System, to safely reduce body weight over five years in people who are considered obese.
Detailed description
The Maestro System is a neuromodulation system that consists of implantable and external components.
Implantable components: two leads (one electrode each for the anterior and posterior intra-abdominal vagal nerve trunks) that are connected to an implantable neuroregulator.
External components: one programmable, battery-powered, ambulatory external controller connected via a small, flexible cable to a cutaneous transmit coil that is positioned externally over the neuroregulator. A clinician programmer that transmits information to the controller and uploads data from the controller.
All non-diabetic subjects will be randomized in a 2:1 allocation to therapy ON or therapy OFF groups. All type 2 diabetes mellitus subjects will be randomized in a 1:1 allocation to therapy ON or therapy OFF groups.
All subjects will receive blinded therapy through the 12-month follow-up visit. All subjects will participate in a medical weight management program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vBloc | Experimental | Device: Therapy ONSubjects implanted with a functional Maestro System device that delivers therapy (Therapy ON). |
| Placebo | Sham comparator | Device: Therapy OFFSubjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Informed consent.
- Body mass index (BMI) ≥ 40 kg/m2 to 45 kg/m2 or BMI ≥ 35 kg/m2 to 39.9 kg/m2 with one or more obesity related co-morbid condition. Co-morbid conditions may include one or more of the following:
- Females or males Note: females of child-bearing potential must have a negative urine pregnancy test at Screen and also within 14 days of implant procedure followed by physician-approved contraceptive regimen for the duration of the study period.
- 18-65 years of age inclusive.
- Type 2 diabetes mellitus subjects (at selected centers, limited to approximately 34 subjects) with:
Key exclusion criteria (31 listed)
- Concurrent chronic pancreatic disease.
- History of Crohn's disease and/or ulcerative colitis.
- History of bariatric surgery, fundoplication, gastric resection or major upper-abdominal surgery (acceptable surgeries include cholecystectomy, hysterectomy).
- History of pulmonary embolism or blood coagulation disorders.
- Clinically significant hiatal hernias known from subject's medical record as or determined by upper endoscopy prior to implant if they have not had one done during the previous 6 months that specifically reported on the presence or absence of hiatal hernia making reference to the Z-line and/or diaphragmatic notch, in order to rule out subjects with hiatal hernia that may require surgical repair (to support exclusion criterion #7).
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 |
|---|---|---|
| Therapy ONAlso: Maestro SystemIntermittent, programmable, intra-abdominal vagal blocking device that delivers therapy (Therapy ON) | Device | vBloc |
| Therapy OFFAlso: Maestro SystemActive intra-abdominal placebo device that delivers no therapy (Therapy OFF) | Device | Placebo |
Primary outcome
Percentage of Excess Weight Loss (EWL) With the Maestro System
Time frame: Baseline and 1 Year
Observe at least a 10% greater percentage excess weight loss (%EWL) with vBloc therapy delivered by the Maestro System compared to sham 12 months following randomization using MetLife Method (ideal body weight is calculated based on Metropolitan Height and Weight Tables)
Rate of System and Procedure-related Serious Adverse Events (SAEs).
Time frame: 1 Year
To estimate the rate of serious, system- and procedure-related adverse events associated with the Maestro System.
1 secondary outcome
Percentage of Participants Achieving 25% Excess Weight Loss (%EWL)
Time frame: Baseline and 1 Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Charles J Billington, MD principal investigator
VA Medical Center, Minneapolis, MN / University of Minnesota
Michael Sarr, MD principal investigator
Mayo Clinic
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy ON and Therapy OFF in people with Obesity, run by ReShape Lifesciences at 15 sites in 2 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 22 inclusion and 31 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: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Australia. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 20 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Excess Weight Loss (EWL) With the Maestro System (time frame: Baseline and 1 Year). 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?
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 24 Aug 2018.