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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
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.
Auckland City Hospital
Auckland, New Zealand
Middlemore Hospital
Auckland, New Zealand
North Shore Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Dunedin Hospital
Dunedin, New Zealand
Wellington Hospital
Wellington, New Zealand
Primary Safety Outcome as assessed by Incidence of serious adverse device effects
Incidence of serious adverse device effects
Time frame: 180 day follow-up
Device and Procedural success
Incidence of successful energy delivery, incidence of serious adverse device effects with 24 hours of procedure
Time frame: 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
Time frame: 180 day and 365 day follow-up
Laboratory Assessments/Cardiometabolic Changes
Assessment of chemistry/serum lab values to evaluate safety and performance
Time frame: 180 day follow up
Adverse Event Rate
Summary of all reported adverse events during the study
Time frame: 365 day follow up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.