Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001255774
Ethics application status
Approved
Date submitted
13/11/2013
Date registered
15/11/2013
Date last updated
15/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
RESOLVE Clinical Trial: Vagal Block for Obesity Triggered Diabetes and Hypertension
Scientific title
The RESOLVE study: A Single-arm Clinical Study to evaluate the efficacy and safety of vagal block using the EnteroMedics Maestro System in the management of patients with Type 2 diabetes mellitus and hypertension
Secondary ID [1] 283577 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 290479 0
Type 2 Diabetes 290490 0
Hypertension 290491 0
Condition category
Condition code
Cardiovascular 290872 290872 0 0
Hypertension
Diet and Nutrition 290881 290881 0 0
Obesity
Metabolic and Endocrine 290882 290882 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 288265 0
Treatment: Devices
Intervention code [2] 288280 0
Treatment: Surgery
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290865 0
The main objectives of this study are to evaluate the efficacy of the EnteroMedics Maestro System in in the management of patients with Type 2 diabetes mellitus and hypertension. Assessed with tests to see changes in HbA1 from baseline, Changes in systolic and diastolic blodd pressures from baseline and tests to see changes in fasting plasma glucose from basline
Timepoint [1] 290865 0
1. Change in HbA1c from baseline at: hospital discharge (post-index procedure), 1, 7, 14, 30 days, 6 months, and quarterly through three (3) years post-implant.
2. Change in systolic and diastolic blood pressures from baseline at: hospital discharge (post-index procedure), 1, 7, 14, 30 days, 6 months, and quarterly through three (3) years post-implant.
3. Change in fasting plasma glucose from baseline at: hospital discharge (post-index procedure), 1, 7, 14, 30 days, 6 months, and quarterly through three (3) years-post-implant.
Primary outcome [2] 290875 0
Evaluate safety of the EnteroMedics Maestro System in the management of patients with Type 2 diabetes mellitus and hypertension. Assessed with tests to see changes in HbA1 from baseline, Changes in systolic and diastolic blodd pressures from baseline and tests to see changes in fasting plasma glucose from basline
Timepoint [2] 290875 0
1. Change in HbA1c from baseline at: hospital discharge (post-index procedure), 1, 7, 14, 30 days, 6 months, and quarterly through three (3) years post-implant.
2. Change in systolic and diastolic blood pressures from baseline at: hospital discharge (post-index procedure), 1, 7, 14, 30 days, 6 months, and quarterly through three (3) years post-implant.
3. Change in fasting plasma glucose from baseline at: hospital discharge (post-index procedure), 1, 7, 14, 30 days, 6 months, and quarterly through three (3) years-post-implant.
Secondary outcome [1] 305497 0
Additionally, the study intends to further explore potential physiologic mechanisms of the Maestro System’s impact on these two disease processes. Assessed through Device-related adverse events at hospital discharge, 1, 7, 14, 30 days, 6 months, and quarterly through three (3) years post-implant. Change in weight from baseline at hospital discharge.

Low Probability risks

Intra-operative

Death, Respiratory complications
Cardiac (anesthesia related),Bleeding,Esophageal perforation,DVT/pulmonary embolus,Electrode misplacement
Electrode malfunction,vagal nerve injury (mechanical)

Post-operative
Esophageal erosion
Organ entrapment or strangulation
Small bowel obstruction
DVT/pulmonary embolism
Vagal nerve injury (mechanical)
Wound dehiscence
Infection, other
Infection, lead location
Infection, neuroregulator location
Electrode dislodgement or malfunction
Neuroregulator malfunction
Neuroregulator migration or erosion
Electric shock
Skin reaction to coil

Medium Probability Risks
Post-operative
Infection, superficial
Inflammation
All risks are assessed using good clinical judgement and reduced by having Implant training; experienced surgical team, Experienced anesthesiology team previous Implant training, surgical technique. Training; stimulation and impedance testing, Replacing any malfunctiong electrodes using Sterile surgical technique; post- op wound care, Design controls; Clinical follow-up and Alternate attachment methods for rection to coil on skin or malfuncting devices.
Timepoint [1] 305497 0
1. Device-related adverse events at hospital discharge, 1, 7, 14, 30 days, 6 months, and quarterly through three (3) years post-implant.
2. Change in weight from baseline at: hospital discharge (post-index procedure), 1, 7, 14, 30 days, 6 months, and quarterly through three (3) years post-implant. This will be reported as absolute, TBL and EWL.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a prospective, single arm clinical study. 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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288261 0
Commercial sector/Industry
Name [1] 288261 0
EnteroMedics 'Registered Trademark' Inc.
Country [1] 288261 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
EnteroMedics 'Registered Trademark' Inc.
Address
2800 Patton Road
St. Paul, MN 55113 United States
Country
United States of America
Secondary sponsor category [1] 286978 0
Commercial sector/Industry
Name [1] 286978 0
Pacific Clinical Research Group (PCRG)
Address [1] 286978 0
Suite G03, 1 Cassins Ave,
North Sydney
NSW
2060
Country [1] 286978 0
Australia

Ethics approval
Ethics application status
Approved

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44234 0
Prof Henry Krum
Address 44234 0
3rd Floor, Burnet Building,
The Alfred
Commercial Road
Prahran, Vic. 3181
Country 44234 0
Australia
Phone 44234 0
+61 3 9903 0042
Fax 44234 0
Email 44234 0
[email protected]
Contact person for public queries
Name 44235 0
Ross Prpic
Address 44235 0
Pacific Clinical Research Group (PCRG)
Suite G03, 1 Cassins Ave
North Sydney
NSW
2060
Country 44235 0
Australia
Phone 44235 0
+61 2 9925 4200
Fax 44235 0
Email 44235 0
[email protected]
Contact person for scientific queries
Name 44236 0
Ross Prpic
Address 44236 0
Pacific Clinical Research Group (PCRG)
Suite G03, 1 Cassins Ave
North Sydney
NSW
2060
Country 44236 0
Australia
Phone 44236 0
+61 2 9925 4200
Fax 44236 0
Email 44236 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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