RecruitingPhase 1NCT05369065

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

Neurotronic Ablation of Arteries for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities (NECTAR IV Trial)


Sponsor

Neurotronic, Inc.

Enrollment

60 participants

Start Date

Jan 27, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 21 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a minimally invasive catheter procedure that uses heat (radiofrequency energy) to treat nerves around arteries (renal and hepatic) as a new approach to controlling both type 2 diabetes and high blood pressure at the same time. Researchers want to see if disrupting these nerve signals improves blood sugar and blood pressure control. **You may be eligible if...** - You are 21–65 years old - You have type 2 diabetes diagnosed within the past 10 years, with HbA1c between 7–9% - You are on metformin and possibly one other oral diabetes drug - You also have high blood pressure (systolic above 140 mmHg) controlled by up to 3 medications - Your BMI is between 27.5 and 40 **You may NOT be eligible if...** - You have type 1 diabetes or need insulin - Your HbA1c is above 9% - You are on beta-blockers or alpha-blockers - You have been hospitalized for dangerously high blood sugar in the past 6 months - You have severe diabetes complications (proliferative retinopathy or peripheral neuropathy) - You have kidney disease (eGFR below 60), liver disease, or a prior kidney/liver transplant - You have severe heart or blood vessel disease - You are pregnant or planning to become pregnant in the next year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

COMBINATION_PRODUCTAblation Treatment

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

DIAGNOSTIC_TESTArterial Angiography Only

Arterial Angiography Only without Intervention

COMBINATION_PRODUCTSingle Arm non-Randomized Ablation Treatment

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


Locations(3)

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, Georgia

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

Tbilisi Heart Center

Tbilisi, Georgia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05369065


Related Trials