Status:
COMPLETED
COMPLEMENT Study- A First in Human Study of Metabolic Neuromodulation Therapy
Lead Sponsor:
Metavention
Conditions:
Diabetes
Endocrine, Nutritional and Metabolic Diseases (E00-E89)
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 inte...
Detailed Description
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.
Eligibility Criteria
Inclusion
- Age 18-65 years
- Uncontrolled T2DM, as evidenced by HbA1c levels, on a consistent oral anti-hyperglycemic drug regimen of at least two different drug classes
- Documented status of stable lifestyle modifications
Exclusion
- Diagnosed type 1 diabetes mellitus
- History or diagnosis of proliferative retinopathy or advanced autonomic neuropathy
- Estimated glomerular filtration rate (GFR) \< 60mL/min/1.73m2
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT02278068
Start Date
October 1 2014
End Date
May 1 2019
Last Update
March 26 2020
Active Locations (6)
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1
Auckland City Hospital
Auckland, New Zealand
2
Middlemore Hospital
Auckland, New Zealand
3
North Shore Hospital
Auckland, New Zealand
4
Christchurch Hospital
Christchurch, New Zealand