NCT04285554CompletedNot Applicable
A Prospective, Single-Arm, Multi-Center Study of the Metavention Integrated Radio Frequency Denervation System to Improve Glycemic Control in Type 2 Diabetic Subjects
Metavention16 sites in 1 country15 target enrollmentStarted: July 28, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 16
- Primary Endpoint
- Rate of Serious Adverse Device Effects
Study Overview
Brief Summary
The objective of this early feasibility study is to evaluate the safety and performance of intravascular hepatic denervation using the Metavention Integrated Radio Frequency Denervation System (iRF System) to improve glycemic control in type 2 diabetes subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥22 and ≤70 years old
- •Type 2 diabetes diagnosis meeting the following criteria:
- •HbA1c > 7.0% and ≤ 9.0% (53 mmol/mol - 75 mmol/mol), AND
- •On at least two anti-diabetic medications; one at the highest tolerated dose with no changes in medication dose in the 12 weeks prior to the first screening visit
- •Waist circumference ≥102 cm (male) and ≥88cm (female)
- •Diagnosis of hypertension: SBP ≥140mmHg OR SBP ≥130mmHg on hypertension medication(s)
- •Documented status of stable lifestyle modifications
- •Women of childbearing potential (WOCBP) must be using at least one acceptable method of contraception throughout the study
Exclusion Criteria
- •BMI >40 kg/m2
- •Diagnosis of type 1 diabetes
- •Use of insulin within 90 days of consent
- •Two or more self-reported or documented severe hypoglycemia events (severe hypoglycemia event defined as: hypoglycemia associated with severe cognitive impairment requiring external assistance for recovery) in the 180 days prior to Index Procedure
- •One or more documented hyperglycemia episodes requiring hospitalization in the 180-days prior to Index Procedure
- •During medication run in period, uncontrolled hyperglycemia noted by a fasting glucose value of >270mg/dL or >360mg/dL at any point that is then confirmed by a second measurement (not on the same day)
- •A history of bariatric surgery, renal denervation, baroreflex activation therapy, or liver transplant, or these procedures are planned in the 365 days following Index Procedure
- •Any surgical procedure within 30 days prior to Index Procedure
- •History of or current symptomatic gallstones (e.g., cholecystitis, bile duct dilatation) without a cholecystectomy being performed (Note: subjects who have had a cholecystectomy are not excluded)
- •Previous hepatobiliary surgery/intervention that in the opinion of the investigator could preclude the ability to perform denervation of the common hepatic artery
- •Currently taking the following medications within 90 days prior to screening and/or there is a need or anticipated need for these medications during the study:
- •Systemic corticosteroids
- •Anticonvulsants
- •Centrally acting sympatholytics
- •Use of anticoagulation therapy which cannot be discontinued from 7 days before to 14 days after the Index Procedure
- •Any other condition(s) that would compromise the safety of the Subject or compromise study quality as judged by the Investigator
- •eGFR <45 mL/min/1.73 m2
- •History or diagnosis of proliferative retinopathy or advanced autonomic neuropathy (e.g., orthostatic hypotension attributable to autonomic neuropathy, a diagnosis of gastroparesis, or a clinical history strongly suggestive of delayed gastric emptying)
- •Myocardial infarction, unstable angina within 1 year prior to consent
- •Widespread atherosclerosis with documented intravascular thrombosis or unstable plaques
- •Documented history or concurrent signs of significant thyroid disease NOTE: If a subject is on chronic thyroid drug treatment, and has a serum TSH test result in normal range at Screening they may enter study
- •Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count <100,000/microliter, or documented coagulopathy
- •Significant alcohol consumption, defined as more than 2 drink units per day (equivalent to 20 g) in women and 3 drink units per day (equivalent to 30 g) in men, or inability to reliably quantify alcohol intake
- •Active substance abuse, based on Investigator judgment, including inhaled or injected drugs, within 1 year prior to the initial screening
- •Significant weight loss within the last 6 months (e.g., >10% total body weight loss)
- •Hepatic decompensation defined as the presence of any of the following:
- •Serum albumin less than 3.5 g/dL
- •International normalized ratio (INR) greater than 1.4 (unless due to therapeutic anticoagulants)
- •Total bilirubin greater than 2 mg/dL with the exception of Gilbert syndrome
- •History of esophageal varices, ascites, or hepatic encephalopathy
- •ALT or AST greater than 200 U/L
- •Diagnosis of liver cirrhosis
- •Chronic liver or biliary disease of the following etiology:
- •History or diagnosis of Hepatitis B
- •History or diagnosis of Hepatitis C
- •History or diagnosis of current active autoimmune hepatitis
- •History or diagnosis of primary biliary cholangitis (PBC)
- •History or diagnosis of primary sclerosing cholangitis
- •History or diagnosis of Wilson's disease
- •History or diagnosis of alpha-1-antitrypsin deficiency
- •History or diagnosis of hemochromatosis
- •History or evidence of drug-induced liver disease, as defined on the basis of typical exposure and history
- •Known bile duct obstruction
- •Suspected or proven liver cancer
- •History of acute or chronic pancreatitis
- •Subjects unable to undergo CT for any reason
- •Currently enrolled in any other investigational trial
- •History of an acute neurologic event including epilepsy, seizures, stroke, and transient ischemic attack.
- •Iliac/femoral artery stenosis precluding insertion of the catheter
- •Human immunodeficiency virus (HIV)
- +12 more not shown
Outcomes
Primary Outcomes
Rate of Serious Adverse Device Effects
Time Frame: Index Procedure through 90 days
The incidence rate of serious adverse device effects (SADEs) from time of Index Procedure through 90 days.
Secondary Outcomes
- Change in glycemic control - C-peptide(30, 90, 180 and 365 days)
- Change in office blood pressure(30, 90, 180 and 365 days)
- Change in glycemic control: HbA1c(30, 90, 180 and 365 days)
- Change in glycemic control - Insulin(30, 90, 180 and 365 days)
- Change in glycemic control - FPG(30, 90, 180 and 365 days)
- Adverse Event rate 365 days(Consent through 365 days)
- Change in liver steatosis(90 and 365 days)
Investigators
Study Sites (16)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose SensorDiabetes MellitusNCT06764069Glucotrack10
Not yet recruiting
Not Applicable
Reperfusion With Hypothermia in Acute Ischemic StrokeIschemic StrokeRevascularizationEndovascular TreatmentReperfusion InjuryNCT05676957Liping Liu30
Completed
Phase 1
Safety/Feasibility of Vonapanitase Following Angioplasty for Patients With Peripheral Artery Disease (PAD) Below the Knee (BTK)Peripheral Artery DiseaseNCT02956993Proteon Therapeutics29
Unknown
Not Applicable
A Clinical Study for the Pan-vascular Interventional Robotic SystemPercutaneous Coronary InterventionPan-vascular Interventional Robotic SystemNCT06110988Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.5
Completed
Not Applicable
Intravitreal Injection of SeeQ CdSe 655 Alt Nanoparticles for Patients With Degenerative Retinal DiseasesRetinitis PigmentosaNCT040087712C Tech Corp20