None listed
Conditions
Brief summary
The RESOLVE study: A Single-arm Clinical Study to evaluate the efficacy and safety of the EnteroMedics Maestro System in the management of patients with Type 2 diabetes mellitus and hypertension. EnteroMedics Maestro Registered Trademark Rechargeable System (“Maestro System”) This is a prospective, single arm clinical study. The main objectives of this study are to evaluate the efficacy and safety of the EnteroMedics Maestro System in the management of patients with Type 2 diabetes mellitus and hypertension. Additionally, the study intends to further explore potential physiologic mechanisms of the Maestro System’s impact on these two disease processes. Up to 25 patients. Patient data will be collected at baseline, index procedure, 1, 7, 14, 30 days, 6 months, and at quarterly intervals through three years post-implant
Interventions
Maestro Registered Trademark Rechargeable System. System consists of a neuromodulation device that delivers intermittent, controllable electrical blocking algorithms, defined as VBLOC Therapy, to the intra-abdominal vagus nerve for the treatment of metabolic disease, including obesity and the obesity-related comorbid conditions of type 2 diabetes mellitus and hypertension.
The Maestro System neuromodulation system consists of the following implantable and external components:
Implantable compo
Maestro Registered Trademark Rechargeable System. System consists of a neuromodulation device that delivers intermittent, controllable electrical blocking algorithms, defined as VBLOC Therapy, to the intra-abdominal vagus nerve for the treatment of metabolic disease, including obesity and the obesity-related comorbid conditions of type 2 diabetes mellitus and hypertension. The Maestro System neuromodulation system consists of the following implantable and external components: 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 rib cage on the mid-axillary line and above the costal margin (a minimum of two or three finger widths above), or a location determined by the surgeon and consistent with device operation. The leads are implanted laparoscopically into the intra-abdominal cavity and the neuroregulator is implanted in a subcutaneous pocket, similar to that used to implant a cardiac pacemaker. External components: 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. The Maestro System works by delivering electronic neuronal blocking algorithms to the anterior and posterior trunks of the intra-abdominal vagus nerve. Blocking of nerve signals carried by these vagal trunks has potential for significant therapeutic benefit, because down-regulates these effects. Duration of the implantation surgery less than 60 Minutes Device remains in-situ permanently. Patient may be involved in activating and recharging device but always under the instruction and supervision of the clinician.
Sponsors
EnteroMedics 'Registered Trademark' Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Body mass index (BMI) 27-40 kg/m2 inclusive Type 2 diabetes mellitus HbA1c levels greater than or equal to 7.0% Systolic blood pressure >130 mmHg 18-70 years of age inclusive Patient is adhering to a stable anti-hypertensive drug regimen (with no changes for a minimum of 2 weeks prior to enrollment) that is expected to be maintained for at least 6 months Females of child-bearing potential must have a negative pregnancy test (blood or urine) at study entrance, and must consent to using an Investigator- approved contraception method for the first 6 months after device implant Patient or patient’s legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by Human Research Ethics Committee (HREC) of the respective investigational site. Patient agrees to comply with all specified follow-up evaluations
Exclusion criteria
1. Concurrent chronic pancreatic disease 2. History of Crohn’s disease and/or ulcerative colitis 3. History of gastric resection or major upper-abdominal surgery (Acceptable surgeries include cholecystectomy, hysterectomy.) 4. History of pulmonary embolism or blood coagulation disorders 5. Clinically significant hiatal hernias 6. Intra-operative exclusion: hiatal hernia requiring surgical repair or extensive dissection at esophagogastric junction at time of surgery 7. Smoking cessation within the prior three months 8. Known genetic cause of obesity (e.g., Prader-Willi Syndrome) 9. DM with associated autonomic neuropathy, e.g., diabetes-associated gastroparesis 10. Current or recent history (within 12 months) of ongoing binge eating disorder, bulimia, or night eating disorder 11. Current alterations in treatment for thyroid disorders (stable treatment regimen for prior three months acceptable) 12. Current alterations in treatment for epilepsy (stable treatment regimen for prior six months acceptable) 13. Current treatment for peptic ulcer disease (previous history acceptable) 14. Chronic treatment with narcotic analgesic drug regimens 15. Current alterations in treatment regimens of anti-cholinergic drugs, including tricyclic antidepressants (stable treatment regimen for prior six months acceptable) 16. 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 17. Presence of permanently implanted electrical powered medical device or implanted gastrointestinal device or prosthesis 18. Significant psychiatric disorders that, in the opinion of the investigator, may interfere with subject’s ability to follow study procedures and/or instructions 19. Pre-operative diet with intent to lose weight prior to surgery 20. Life expectancy < 12 months 21. Currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints
Outcome results
None listed