Ablation of Arteries for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-65
SponsorNeurotronic, Inc.
About this trial
This study is to assess the safety and performance of the Neurotronic Infusion Catheter and ethanol denervation of renal and hepatic arteries for the treatment of patients with Type 2 Diabetes (T2DM), Hypertension and Obesity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 21 and ≤ 65 years at time of enrollment.
Fasting plasma glucose ≥ 140 mg/dl (7.8 mmol/l) and ≤ 270 mg/dL (15 mmol/L)
HbA1c levels ≥ 7.0% and ≤ 9.0% (53-75 mmol/mol)
Triglyceride level < 400 mg/dL (4.52 mmol/L)
Disqualifiers
T1DM or poorly controlled T2DM (defined as HbA1c > 9.0% or use insulin as medication to control glucose level).
Office diastolic blood pressure < 90 mmHg.
Current use of > 3 hypertension medications.
Currently on beta blockers or alpha blockers.
Trial design
Design model
Parallel
Treatments tested in this trial
Ablation Treatment
Combination productDenervation of renal and common hepatic arteries by ethanol ablation with the Neurotronic Infusion Catheter
Arterial Angiography Only
Diagnostic testArterial Angiography Only without Intervention
Single Arm non-Randomized Ablation Treatment
Combination productDenervation of renal and common hepatic arteries by ethanol ablation with the Neurotronic Infusion Catheter
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Ablation TreatmentExperimental treatment 1 intervention
Group B: Sham TreatmentSham comparator 1 intervention
Group C: Single Arm non-Randomized TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of serious device- and procedure-related complications at 30 days post procedure.
This composite endpoint is defined as: * death * flow-limiting dissection at one or more of the treated arteries requiring intervention. * Type III perforation of the treated artery requiring intervention. * bleeding requiring transfusion. * severe or occlusive thrombosis of the treated artery beds * clinically significant distal embolization of the treated artery beds * clinically significant damage to kidneys and/or liver
Time frame
30 Days2
Device success
The device success, defined as successful introduction of the catheter, navigation to the treatment site, and infusion of the chemical to the intended area without device malfunction requiring aborting the procedure.
Time frame
Procedure DaySecondary outcomes
1
Glycemic Control - HbA1c
Change in HbA1c will be analyzed by absolute and relative changes. Percent subjects with decreased HbA1c will also be analyzed.
Time frame
Discharge up to 5 Days, 1 month, 3 months, 6 months, 12 months, and 24 months. Optional 3, 4 and 5 years2
Glycemic Control - fasting glucose
Change in fasting glucose will be analyzed by absolute and relative changes. Percent subjects with decreased fasting glucose will also be analyzed.
Time frame
Discharge up to 5 Days, 1 month, 3 months, 6 months, 12 months, and 24 months. Optional 3, 4 and 5 years3
Hypertension Control - ABPM
Change in ABPM will be analyzed by systolic, diastolic, and mean arterial pressure, absolute and relative changes of ABPM blood pressure. Percent subjects with decrease blood pressure will also be analyzed.
Time frame
Discharge up to 5 Days, 1 month, 3 months, 6 months, 12 months, and 24 months. Optional 3, 4 and 5 years4
Hypertension Control - Office Blood Pressure
Change in office blood pressure will be analyzed by systolic, diastolic, and mean arterial pressure, absolute and relative changes of office blood pressure. Percent subjects with decrease blood pressure will also be analyzed.
Time frame
Discharge up to 5 Days, 1 month, 3 months, 6 months, 12 months, and 24 months. Optional 3, 4 and 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Neurotronic, Inc.
Lead sponsor
Libra Medical
Collaborator
Source ClinicalTrials.gov