NCT04285554
Completed
Not 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
Metavention8 sites in 1 country15 target enrollmentJuly 28, 2020
ConditionsDiabetes Mellitus, Type 2
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Metavention
- Enrollment
- 15
- Locations
- 8
- Primary Endpoint
- Rate of Serious Adverse Device Effects
- Status
- Completed
- Last Updated
- 3 years ago
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.
Investigators
Eligibility Criteria
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
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)
Study Sites (8)
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
Not yet recruiting
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