Health Trials

Arterial Ablation for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities

ConditionsDiabetes Mellitus, Type 2Hypertension
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-65
SponsorNeurotronic, Inc.

About this trial

This study is assess the safety and performance of the Neurotronic Infusion catheter for treatment of patients with Type 2 Diabetes (T2DM) and hypertension.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 21 and ≤ 65 years at time of enrollment.

Disease diagnosed

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)

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Neurotronic Infusion Catheter

    Combination product

    Denervation of renal and common hepatic arteries by ethanol ablation with the Neurotronic Infusion Catheter

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Ablation 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 Days
2

Device success

The device success, defined as successful introduction of the catheter, navigation to the treatment site, and infusion of the chemical to the perivascular without device malfunction that requiring aborting the procedure.

Time frame
During the procedure

Secondary outcomes

1

Glycemic Control:

Change of fasting glucose and HbA1c will be analyzed by absolute and relative changes. Percent subjects with decreased fasting glucose and HbA1c will also be analyzed.

Time frame
1 month, 3 months, 6 months, 12 months, and 24 months. Optional 3, 4 and 5 years to understand the long-term effects of the treatment.
2

Hypertension Control:

Change of blood pressure will be analyzed by systolic, diastolic, and mean arterial pressure, absolute and relative changes of ABPM and office blood pressure. Percent subjects with decrease blood pressure will also be analyzed.

Time frame
1 month, 3 months, 6 months, 12 months, and 24 months. Optional 3, 4 and 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Neurotronic, Inc.

Lead sponsor

Libra Medical

Collaborator

Source ClinicalTrials.gov
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