ObesityReChargeNCT01327976
The Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity
A study testing vBloc (Active Device) in people with Obesity, run by ReShape Lifesciences at 10 sites in 2 countries.
Trial summary
The study evaluated the safety and efficacy of the vBloc Therapy delivered by the Maestro Rechargeable System compared to a sham control for the treatment obesity. The Maestro Rechargeable System delivers intermittent, electrical blocking signals to the anterior and posterior trunks of the intra-abdominal vagus nerve… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- vBloc (Active Device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 10 sitesin 2 countries
- Study dates
- May 2011to Jan 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed 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 conditions. Co-morbid conditions may include one or more of the following:
- Type 2 diabetes mellitus as defined in inclusion criteria #5 (limited to 10% of randomized subjects)
- 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:
- Glycosylated hemoglobin (HbA1c) 7.0 - 10.0 % inclusive at screening visit. (Undiagnosed subjects that are found to have a HbA1c value between 7-10% at screening must see their primary physician for diagnosis and medical treatment before continuing in trial)
- Onset: 12 years or less since initial diagnosis.
- Currently not using insulin therapy, GLP-1 (glucagon-like peptide-1) receptor agonists (e.g., exenatide, liraglutide) 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 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 (> 5 cm) known from subject's medical record or determined by barium swallow (upper GI x-ray) or upper endoscopy per PI discretion prior to implant.
- Current cirrhosis, 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 prescription weight-loss drug therapy within the prior three months and the use of prescription drug therapy or the use of 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).
- Weight loss of more than 10% of body weight in the previous 12 months.
- Physician-prescribed diet with intent to lose weight prior to surgery (note:
- study subject may continue any personal eating plan they were on prior to study enrollment [see exclusion criterion #24]
- 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 oncologic radiation during the course of the trial.
- Psychiatric disorders (including untreated severe depression, schizophrenia, substance abuse, bulimia nervosa, etc.) or limited intellectual functioning which would potentially compromise the participant's ability to fully comprehend and/or cooperate with the study protocol. Psychiatric disorders will be established by a review of subject's medical history. For depression, a BDI (Beck Depression Inventory) score ≥ 29 will be considered to indicate severe depression.
- 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
10 sites in 2 countries.
10 sites in 2 countries
United States8 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Scripps Clinic Nutrition & Metabolic Research Center
La Jolla, California, 92037
University of Minnesota
Minneapolis, Minnesota, 55455
Oregon Health & Science University
Portland, Oregon, 97239
Virginia Commonwealth University
Richmond, Virginia, 23219
Mayo Clinic Rochester
Rochester, Minnesota, 55905
HonorHealth (formerly Scottsdale Healthcare Bariatric Center)
Scottsdale, Arizona, 85258
Stanford University
Stanford, California, 94305
Australia2 sites
Institute of Weight Control
Baulkham Hills, New South Wales
Adelaide Bariatric Centre
Bedford Park, SA
About this study
Official title: A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity
The study evaluated the safety and efficacy of the vBloc Therapy delivered by the Maestro Rechargeable System compared to a sham control for the treatment obesity. The Maestro Rechargeable System delivers intermittent, electrical blocking signals to the anterior and posterior trunks of the intra-abdominal vagus nerve (termed vBloc Therapy) and is designed to reduce sensations of hunger and produce satiety leading to weight loss. After approval from the institutional review board, subjects provided written consent and were randomized in a 2 to 1 allocation to vBloc group (with laparoscopic placement of the leads and neuroregulator) or the sham group (placement of a custom sham neuroregulator only) on double-blinded basis. Both groups received similar diet and exercise counseling. Weight, adverse events, clinical laboratories, ECGs, eating questionnaires and quality of life data were evaluated throughout the 12 month study duration.
Read the detailed description
The Maestro® Rechargeable System is a neuromodulation system.
All subjects will be randomized in a 2:1 allocation to vBloc or Sham.
All subjects will be followed through the 12-month follow-up visit. Subjects in the Sham group who choose to have an active device will undergo a second surgery to receive the active device after study unblinding.
- Conditions
- Obesity
- Being tested
- vBloc (Active Device), Sham (Non-active Device)
- Keywords
- Obesity, Bariatric surgery, Excess weight loss, Vagus nerve, Vagal blocking, vBloc Therapy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vBloc (Active Device)Device
Also called Maestro® Rechargeable System
Active device will deliver vBloc Therapy
Sham (Non-active Device)Device
Also called Maestro® Rechargeable System
Functional non-active control device will deliver no vBloc Therapy
| Study group | Role | What they receive |
|---|---|---|
| vBloc (Active Device) | Active comparator | The treatment group will receive a functional device that will deliver charge to the vagus nerve during the study period Receives: Device: vBloc (Active Device) |
| Sham (Non-active Device) | Sham comparator | The control group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period Receives: Device: Sham (Non-active Device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Experiencing Implant/Revision Procedure, Device or Therapy Related Serious Adverse Events (SAEs).
To demonstrate that the implant/revision procedure, device and therapy related serious adverse event rate in the vBloc group at 12 months post-implant is significantly lower than 15%.
Measured: 12 months
Percentage of Excess Weight Loss (EWL) by Body Mass Index (BMI) Method.
Observe at least a 10% greater excess body weight loss (EWL) from randomization with the Maestro System after 12 months of vBloc Therapy compared to Sham by body mass index (BMI) method. (Body mass index is calculated by dividing body weight (kg) by body height (m) squared (BMI=kg/m2)).
Measured: 12 months
Percentage Responder Rate in the Treatment Arm.
The second co-primary effectiveness endpoint was based on responder rates with the following two requirements: (i) at least 55% of vBloc subjects would achieve a %EWL of at least 20%; and (ii) at least 45% of vBloc subjects would achieve a %EWL of at least 25%.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2013
- Study completionJan 2021 (estimated)
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.
- Publications (2)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- ReShape Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Sarr, M.D., Principal investigator, Mayo ClinicCharles Billington, M.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327976
- Sponsor's protocol ID
- IDE G070025
- Acronym
- ReCharge
- Status last verified
- Aug 2017
- First submitted
- 31 Mar 2011
- Last updated
- 30 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Apovian CM, Shah SN, Wolfe BM, Ikramuddin S, Miller CJ, Tweden KS, Billington CJ, Shikora SA. Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial. Obes Surg. 2017 Jan;27(1):169-176. doi: 10.1007/s11695-016-2325-7.
PubMed 27506803Ikramuddin S, Blackstone RP, Brancatisano A, Toouli J, Shah SN, Wolfe BM, Fujioka K, Maher JW, Swain J, Que FG, Morton JM, Leslie DB, Brancatisano R, Kow L, O'Rourke RW, Deveney C, Takata M, Miller CJ, Knudson MB, Tweden KS, Shikora SA, Sarr MG, Billington CJ. Effect of reversible intermittent intra-abdominal vagal nerve blockade on morbid obesity: the ReCharge randomized clinical trial. JAMA. 2014 Sep 3;312(9):915-22. doi: 10.1001/jama.2014.10540.
PubMed 25182100
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity
- ClinicalTrials.gov ID
- NCT01327976
- Acronym / sponsor ID
- ReCharge / IDE G070025
- Conditions
- Obesity
- Keywords
- Obesity, Bariatric surgery, Excess weight loss, Vagus nerve, Vagal blocking, vBloc Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 239 participants (actual)
- Lead sponsor
- ReShape LifesciencesIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jan 2021 (estimated)
- First posted
- 4 Apr 2011 (estimated)
- Results
- Posted 27 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluated the safety and efficacy of the vBloc Therapy delivered by the Maestro Rechargeable System compared to a sham control for the treatment obesity. The Maestro Rechargeable System delivers intermittent, electrical blocking signals to the anterior and posterior trunks of the intra-abdominal vagus nerve (termed vBloc Therapy) and is designed to reduce sensations of hunger and produce satiety leading to weight loss. After approval from the institutional review board, subjects provided written consent and were randomized in a 2 to 1 allocation to vBloc group (with laparoscopic placement of the leads and neuroregulator) or the sham group (placement of a custom sham neuroregulator only) on double-blinded basis. Both groups received similar diet and exercise counseling. Weight, adverse events, clinical laboratories, ECGs, eating questionnaires and quality of life data were evaluated throughout the 12 month study duration.
Detailed description
The Maestro® Rechargeable System is a neuromodulation system.
All subjects will be randomized in a 2:1 allocation to vBloc or Sham.
All subjects will be followed through the 12-month follow-up visit. Subjects in the Sham group who choose to have an active device will undergo a second surgery to receive the active device after study unblinding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vBloc (Active Device) | Active comparator | Device: vBloc (Active Device)The treatment group will receive a functional device that will deliver charge to the vagus nerve during the study period |
| Sham (Non-active Device) | Sham comparator | Device: Sham (Non-active Device)The control group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Signed 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 conditions. 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:
Key exclusion criteria (32 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 (> 5 cm) known from subject's medical record or determined by barium swallow (upper GI x-ray) or upper endoscopy per PI discretion prior to implant.
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 |
|---|---|---|
| vBloc (Active Device)Also: Maestro® Rechargeable SystemActive device will deliver vBloc Therapy | Device | vBloc (Active Device) |
| Sham (Non-active Device)Also: Maestro® Rechargeable SystemFunctional non-active control device will deliver no vBloc Therapy | Device | Sham (Non-active Device) |
Primary outcome
Percentage of Subjects Experiencing Implant/Revision Procedure, Device or Therapy Related Serious Adverse Events (SAEs).
Time frame: 12 months
To demonstrate that the implant/revision procedure, device and therapy related serious adverse event rate in the vBloc group at 12 months post-implant is significantly lower than 15%.
Percentage of Excess Weight Loss (EWL) by Body Mass Index (BMI) Method.
Time frame: 12 months
Observe at least a 10% greater excess body weight loss (EWL) from randomization with the Maestro System after 12 months of vBloc Therapy compared to Sham by body mass index (BMI) method. (Body mass index is calculated by dividing body weight (kg) by body height (m) squared (BMI=kg/m2)).
Percentage Responder Rate in the Treatment Arm.
Time frame: 12 months
The second co-primary effectiveness endpoint was based on responder rates with the following two requirements: (i) at least 55% of vBloc subjects would achieve a %EWL of at least 20%; and (ii) at least 45% of vBloc subjects would achieve a %EWL of at least 25%.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27506803Apovian CM, Shah SN, Wolfe BM, Ikramuddin S, Miller CJ, Tweden KS, Billington CJ, Shikora SA. Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial. Obes Surg. 2017 Jan;27(1):169-176. doi: 10.1007/s11695-016-2325-7.
- Derived from this study: PubMed 25182100Ikramuddin S, Blackstone RP, Brancatisano A, Toouli J, Shah SN, Wolfe BM, Fujioka K, Maher JW, Swain J, Que FG, Morton JM, Leslie DB, Brancatisano R, Kow L, O'Rourke RW, Deveney C, Takata M, Miller CJ, Knudson MB, Tweden KS, Shikora SA, Sarr MG, Billington CJ. Effect of reversible intermittent intra-abdominal vagal nerve blockade on morbid obesity: the ReCharge randomized clinical trial. JAMA. 2014 Sep 3;312(9):915-22. doi: 10.1001/jama.2014.10540.
- 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.
Michael Sarr, M.D. principal investigator
Mayo Clinic
Charles Billington, M.D. principal investigator
University of Minnesota
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vBloc (Active Device) in people with Obesity, run by ReShape Lifesciences at 10 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 21 inclusion and 32 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 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 27 May 2016). 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 Subjects Experiencing Implant/Revision Procedure, Device or Therapy Related Serious Adverse Events (SAEs). (time frame: 12 months). The study lists 3 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 NCT01327976, which also lists 2 linked publications.
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 30 Aug 2017.