NCT05363761

Arterial Ablation 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 III Trial)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Neurotronic, Inc. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study is a prospective, single-arm, multi-center trial to evaluate the safety and performance of use of the Neurotronic Infusion Catheter for chemical denervation of renal and hepatic arteries for treatment of patients with type 2 diabetes, hypertension, and obesity.

Conditions

• Diabetes Mellitus, Type 2
• Hypertension

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Neurotronic Infusion Catheter	Denervation of renal and common hepatic arteries by ethanol ablation with the Neurotronic Infusion Catheter

Timeline

• Start date: 2022-04-19
• Primary completion: 2025-01-01
• Completion: 2029-01-01
• First posted: 2022-05-06
• Last updated: 2023-03-21

Locations

3 sites across 2 countries: Panama, Paraguay

Regulatory

• FDA-regulated drug study
• FDA-regulated device study