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

NCT05369065 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-03-22

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Libra Medical

    collaborator OTHER

  • Neurotronic, Inc.

    lead INDUSTRY

Principal Investigators

  • John Chen, PhD · Neurotronic, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-27
Primary Completion
2025-01-31
Completion
2029-01-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • Georgia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05369065 on ClinicalTrials.gov