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

NCT04232774 | Completed

• 1 other identifier: PR 2010
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The study is to assess the safety and feasibility of chemical denervation of multiple artery beds for the treatment of Type 2 diabetes (T2DM) and its comorbidities.

Conditions

Type 2 Diabetes Mellitus With Circulatory Complciation

Keywords

Denervation; T2DM; Hypertension; Obesity

Outcome Measures

Primary Outcomes (1)

• Incidence of Serious Device- and Procedure-Related Complications

  This composite endpoint is defined as: * death * flow-limiting dissection of the treated one or more of the arteries requiring intervention * perforation of the treated artery requiring intervention * bleeding requiring transfusion due to severe leakage at treatment site * severe or occlusive thrombosis of the treated artery beds * distal embolization of the treated artery beds

  at 30 Days post procedure

Secondary Outcomes (7)

• Glycemic Control (1)

  at baseline and at post-procedure: 2-week, 1-month, 3-month, 6-month, 12-month and 24-month follow-up visits. Also, optionally at 3-,4- and 5-year post-procedure follow-up visits.

• Glycemic Control (2)

  at baseline and at post-procedure: 2-week, 1-month, 3-month, 6-month, 12-month and 24-month follow-up visits. Also, optionally at 3-,4- and 5-year post-procedure follow-up visits.

• Hypertension Control

  at baseline and at post-procedure: 2-week, 1-month, 3-month, 6-month, 12-month and 24-month follow-up visits. Also, optionally at 3-,4- and 5-year post-procedure follow-up visits.

• Weight Control (1)

  at baseline and at post-procedure: 2-week, 1-month, 3-month, 6-month, 12-month and 24-month follow-up visits. Also, optionally at 3-,4- and 5-year post-procedure follow-up visits.

• Weight Control (2)

  at baseline and at post-procedure: 2-week, 1-month, 3-month, 6-month, 12-month and 24-month follow-up visits. Also, optionally at 3-,4- and 5-year post-procedure follow-up visits.

Study Arms (1)

Treated by the study device

EXPERIMENTAL

Device: The Neurotronic arterial ablation catheter

Interventions

The Neurotronic arterial ablation catheter DEVICE

a sterile, single use catheter (device) for delivering chemical agent to achieve perivascular denervation.

Also known as: NAA

Treated by the study device

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 22 and ≤ 70 years at time of enrollment.
• Diagnosed with uncontrolled T2DM with baseline.
• Fasting plasma glucose ≥ 155 mg/dl (8.6 mmol/l)
• HbA1c levels ≥ 7.5% and \< 10% (58-86 mmol/mol)\]
• On oral anti-hyperglycemic drug regimen of at least two different drug classes, and one of the two being metformin ≥ 1500 mg/day
• History of positive response to metformin dosage escalation, i.e., HbA1c reduction of 0.5% or more
• Diagnosed hypertension with baseline office blood pressure of SBP of ≥ 150 mmHg and ≤ 180 mmHg and DBP ≥ 90 mmHg.
• BMI between 27.5 and 45 kg/m2 and weight \< 400lbs.
• Vessel diameter of 3 mm to 7 mm with a minimum arterial treatable length of 20 mm.

You may not qualify if:

• T1DM or poorly controlled T2DM (defined as HbA1c \>10.0%).
• Hypoglycemia unawareness or serious hypoglycemia with loss of consciousness or confusion sufficient to prevent self-treatment in last 6 months;
• Diagnosed proliferative retinopathy or evidence of peripheral neuropathy.
• Lack of appropriate treatment site or anatomy precluding the intervention of the target arteries.
• History of prior target artery intervention including balloon angioplasty, stenting, etc.
• Arterial stenosis \>50% of the normal diameter segment (diameter stenosis, compared to the angiographically normal proximal or distal segment).
• Any abnormality or disease in one or more of the target arteries that, per the physician assessment, precludes the safe insertion of the guiding catheter (including, but not limited to, artery aneurysm, excessive tortuosity, artery calcification)
• Known or suspected secondary hypertension, such as Cushing's disease or Cushing's Syndrome, hyperaldosteronism, pheochromocytoma, thyroid and parathyroid abnormalities, history of pre-eclampsia, onset of hypertension prior to the age of 18.
• Use of nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment.
• Severe or unstable cardiovascular comorbidities, such as AMI or ACS, cardiac valve stenosis, pulmonary embolism, heart failure with NYHA Class III or IV, chronic atrial fibrillation, primary pulmonary hypertension, COPD.
• Renal transplant, history of nephrectomy or single kidney, renal tumor/cancer, known non-functioning kidney, unequal renal size (\>2 cm difference in renal length between kidneys associated with a chronic kidney disease or a deterioration of the kidney function), chronic renal deficiency with eGFR ≤60ml/min/1.73m2, or on chronic renal replacement therapy.
• Liver transplant.
• Gastrointestinal permanent anatomic alteration surgery
• Bleeding disorders, such as bleeding diathesis, thrombocytopenia, and severe anemia.
• Systemic infection that the investigator judges would pose unacceptable procedural risks to the subject.

Sponsors & Collaborators

• Neurotronic, Inc.: lead
• Libra Medical: collaborator

Study Sites (1)

Sanatorio Italiano - Centro de Intervenciones Endovasculares

Asunción, Paraguay

Location

MeSH Terms

Conditions

Hypertension; Obesity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John Chen

  Neurotronic, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-center, non-randomized, open label first-in-human (FIH) study.

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 18, 2020
• Study Start: November 4, 2019
• Primary Completion: January 17, 2023
• Study Completion: January 17, 2023
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)