NCT05369065

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Neurotronic, Inc. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Prospective, multicenter safety and performance study including two groups: a double-blind, randomized, sham controlled cohort and a single-arm treatment non-randomized cohort. Eligible subjects in the randomized cohort will be randomized in a 2:1 ratio to the ablation treatment group or to the sham treatment (control) group. Eligible subjects in the non-randomized cohort will all receive the ablation treatment. Randomized subjects and the follow-up investigators/study coordinators will be blinded to the treatment scheme for at least 6 months. The non-randomized cohort will not be blinded. Subjects in the randomized cohort that are assigned to sham (control) will be allowed to cross over to the treatment group if desired after 6 to 12 months if they continue to meet the inclusion criteria.

Conditions

• Diabetes Mellitus, Type 2
• Hypertension

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Ablation Treatment	Denervation of renal and common hepatic arteries by ethanol ablation with the Neurotronic Infusion Catheter
DIAGNOSTIC_TEST	Arterial Angiography Only	Arterial Angiography Only without Intervention
COMBINATION_PRODUCT	Single Arm non-Randomized Ablation Treatment	Denervation of renal and common hepatic arteries by ethanol ablation with the Neurotronic Infusion Catheter

Timeline

• Start date: 2022-01-27
• Primary completion: 2025-01-01
• Completion: 2029-01-01
• First posted: 2022-05-11
• Last updated: 2023-03-22

Locations

3 sites across 1 country: Georgia

Regulatory

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