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The purpose of this research study is to collect information about a new treatment for Type 2 Diabetes Mellitus (T2DM), using a medical device called the Metabolic Neuromodulation System which is intended to help regulate blood glucose levels in patients whose (T2DM) is not well controlled despite treatment with multiple medications. The medical device delivers low-level radiofrequency energy through the wall of the blood vessel to the liver to disrupt the nerves that lead to the liver. Previous research has shown that disrupting these nerves may lead to a lowering of blood sugar levels.
Prospective, First-in-Human (FIH), multi-center, non-randomized trial to evaluate the initial safety and performance of hepatic sympathetic denervation to aid in glycemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metabolic Neuromodulation System (MNS) | Experimental | Hepatic sympathetic denervation therapy to aid in glycemic control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metabolic Neuromodulation System (MNS) | Device | Prospective, First-in-Human (FIH), multi-center, non-randomized trial to evaluate the initial safety and performance of hepatic sympathetic denervation to aid in glycemic control. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Outcome as assessed by Incidence of serious adverse device effects | Incidence of serious adverse device effects | 180 day follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Device and Procedural success | Incidence of successful energy delivery, incidence of serious adverse device effects with 24 hours of procedure | intra operative |
| Glycemic control | Number of subjects with a decrease in HbA1c, change in plasma glucose based on fasting glucose and oral glucose tolerance test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Webster, Prof | Auckland City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auckland City Hospital | Auckland | New Zealand | ||||
| Middlemore Hospital |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D008659 | Metabolic Diseases |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| 180 day and 365 day follow-up |
| Laboratory Assessments/Cardiometabolic Changes | Assessment of chemistry/serum lab values to evaluate safety and performance | 180 day follow up |
| Adverse Event Rate | Summary of all reported adverse events during the study | 365 day follow up |
| Auckland |
| New Zealand |
| North Shore Hospital | Auckland | New Zealand |
| Christchurch Hospital | Christchurch | New Zealand |
| Dunedin Hospital | Dunedin | New Zealand |
| Wellington Hospital | Wellington | New Zealand |