VBLOC study: Maestro Weight Loss System
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of this trial is to determine the safety and efficacy of the Maestro System for weight loss in obese human subjects.
Recruiting Status:
CompletedStanford Recruiting Status:
No longer recruitingCondition(s):
Intervention(s):
- Device: Maestro Weight Loss System
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to 65 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can not participate as controls.Key Inclusion Criteria:
1. Informed consent
2. Body mass index (BMI) ≥ 40 kg/m2 to 45 kg/m2 or BMI ≥ 35 kg/m2 to 39.9 kg/m2
with at least one obesity related co-morbid condition. Co-morbid conditions may
include one or more of the following and will be documented on the appropriate case
report form:
• 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
• treated or untreated with systolic ≥140 mmHg and/or diastolic ≥90 mmHg
• treated with systolic <140 mmHg and/or diastolic <90 mmHg
• Dyslipidemia as defined by total cholesterol ≥200 or LDL ≥130
• treated or untreated with total cholesterol ≥200 or LDL ≥130
• treated with total cholesterol <200 or LDL <130
• Sleep apnea syndrome (confirmed by overnight p02 studies)
• Obesity related cardiomyopathy
3. 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
4. 18-65 years of age inclusive
5. Type 2 diabetes mellitus subjects (at selected centers, limited to approximately 34
subjects) with:
• Glycosylated hemoglobin (Hb A1c) 7-10 % 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 and, if applicable, stable insulin regimen defined as total
daily dosage within + 2 units within past 3 months or, for subjects on a sliding
scale insulin regimen, no change in insulin prescription regimen within the
past 3 months.
• Stable Hb A1c levels
o three consecutive levels each at least 6 weeks apart and within + 0.5 %
inclusive (total range); or,
o two consecutive levels at least 12 weeks apart and within ± 0.5 %
inclusive; or,
o two consecutive levels at least 6 weeks apart and within ± 0.2 % inclusive
• Creatinine within normal reference range
• No history of proliferative retinopathy
• No history peripheral neuropathy
• No history of autonomic neuropathy
• No history of coronary artery disease, with or without angina pectoris
• No history of peripheral vascular disease
6. Failure to respond to a supervised diet/exercise programs in which the subject was
engaged for at least 6 months within the last five years
7. Ability to complete all study visits and procedures
Key Exclusion Criteria:
*** PLEASE NOTE: STANFORD IS NOT A PARTICIPATING INSTITUTION FOR DIABETIC PATIENTS, THUS DIABETES IS AN EXCLUSION CRITERIA FOR JOINING THIS TRIAL HERE AT STANFORD.
1. Concurrent chronic pancreatic disease
2. History of Crohn’s disease and/or ulcerative colitis
3. History of bariatric surgery, fundoplication, gastric resection or major upperabdominal
surgery (acceptable surgeries include cholecystectomy, hysterectomy.)
4. History of pulmonary embolism or blood coagulation disorders
5. Clinically significant hiatal hernias known from subject’s medical record as or
determined by 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)
6. Current portal hypertension and/or esophageal varices
7. Intra-operative exclusion: hiatal hernia requiring surgical repair or extensive
dissection at esophagogastric junction at time of surgery
8. 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
9. Smoking cessation within the prior six months
10. Known genetic cause of obesity (e.g., Prader-Willi Syndrome)
11. Overall sustained reductions of more than 10% of body weight in the previous 12
months
12. Physician-prescribed pre-operative diet with intent to lose weight prior to surgery
(note:
[1] study subject may continue any personal diet they were on prior to study
enrollment [see exclusion criterion #24
[2] standardized EMPOWER weight management program initiated in all
subjects at time of activation, approximately two weeks after implant)
13. Current type 1 diabetes mellitus (DM)
14. Current or recent history (within 12 months) of ongoing bulimia
15. Current alterations in treatment for thyroid disorders (stable treatment regimen for
prior three months acceptable)
16. Current alterations in treatment for epilepsy (stable treatment regimen for prior six
months acceptable)
17. Current treatment for peptic ulcer disease (previous history acceptable)
18. Chronic treatment (more than 4 weeks of daily use) with narcotic analgesic drug
regimens (treatment with non-steroidal anti-inflammatory drugs acceptable)
19. Current alterations in treatment regimens of anti-cholinergic drugs, including tricyclic
antidepressants (stable treatment regimen for prior six months acceptable)
20. 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
21. Presence of permanently implanted electrical powered medical device or implanted
gastrointestinal device or prosthesis (e.g., pacemakers, implanted defibrillators,
neurostimulators etc.)
22. Planned or contemplated use of Magnetic Resonance Imaging (MRI) during the
course of the trial
23. Significant psychiatric disorders that, in the opinion of the investigator, may interfere
with subject’s ability to follow study procedures and/or instructions
24. Current, active member of an organized weight loss program (e.g., Weight Watchers,
TOPS)
25. Current participant in another weight loss study or other clinical trials
26. Have a friend or family member who is currently participating or is planning to
participate in this clinical trial
27. Patient reported:
o inability to walk for about 10 minutes without stopping
o feeling of pain in chest when doing physical activity
o 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.
28. Clinically significant cardiac rhythm disorder that requires either medical and/or
surgical intervention (e.g., paroxysmal or chronic atria fibrillation).
Additional Study Details
Official Title:
EMPOWER Clinical Trial: Vagal Blocking for Obesity ControlAnticipated start date:
3/17/2008Lead Sponsor:
EnteroMedics IncCollaborator(s):
- EnteroMedics Inc
Investigator(s):
Study Type:
InterventionalPurpose:
OtherAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- To determine the safety and efficacy of the Maestro System for weight loss in obese subjects.
Total Number to be Enrolled:
300Total Number to be Enrolled at Stanford:
21More Information
Secondary ID(s):
- Protocol ID # 10632
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
8/27/2008PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
Help
Administrator Login