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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02278068




Registration number
NCT02278068
Ethics application status
Date submitted
23/10/2014
Date registered
29/10/2014
Date last updated
23/03/2017

Titles & IDs
Public title
COMPLEMENT Study- A First in Human Study of Metabolic Neuromodulation Therapy
Scientific title
A First in Human (FIH) Clinical Study to Assess Safety and Performance of Hepatic Sympathetic Denervation for Treatment of Inadequately Controlled Type 2 Diabetic Subjects on Oral Antihyperglycemic Agents.
Secondary ID [1] 0 0
MV-2014-ANZ-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Endocrine, Nutritional and Metabolic Diseases (E00-E89) 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Metabolic Neuromodulation System (MNS)

Experimental: Metabolic Neuromodulation System (MNS) - Hepatic sympathetic denervation therapy to aid in glycemic control


Treatment: Devices: Metabolic Neuromodulation System (MNS)
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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Safety Outcome as assessed by Incidence of serious adverse device effects - Incidence of serious adverse device effects
Timepoint [1] 0 0
180 day follow-up
Secondary outcome [1] 0 0
Device and Procedural success - Incidence of successful energy delivery, incidence of serious adverse device effects with 24 hours of procedure
Timepoint [1] 0 0
intra operative
Secondary outcome [2] 0 0
Glycemic control - Number of subjects with a decrease in HbA1c, change in plasma glucose based on fasting glucose and oral glucose tolerance test
Timepoint [2] 0 0
180 day and 365 day follow-up
Secondary outcome [3] 0 0
Laboratory Assessments/Cardiometabolic Changes - Assessment of chemistry/serum lab values to evaluate safety and performance
Timepoint [3] 0 0
180 day follow up
Secondary outcome [4] 0 0
Adverse Event Rate - Summary of all reported adverse events during the study
Timepoint [4] 0 0
365 day follow up

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosed type 1 diabetes mellitus

- History or diagnosis of proliferative retinopathy or advanced autonomic neuropathy

- Estimated glomerular filtration rate (GFR) < 60mL/min/1.73m2

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Dunedin
Country [4] 0 0
New Zealand
State/province [4] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Metavention
Address
Country

Ethics approval
Ethics application status

Summary
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 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.
Trial website
https://clinicaltrials.gov/show/NCT02278068
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark Webster, Prof
Address 0 0
Auckland City Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02278068