Type 2 Diabetes Mellitus With Circulatory ComplciationNECTARNCT04232774
Neurotronic Ablation of Arteries for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities
A study testing The Neurotronic arterial ablation catheter in people with Type 2 Diabetes Mellitus With Circulatory Complciation, run by Neurotronic, Inc. at 1 site in Paraguay.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus With Circulatory Complciation
- What is being tested?
- The Neurotronic arterial ablation catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteParaguay
- Study dates
- 4 Nov 2019to 17 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
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- 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.
- Known hypersensitivity to contrast media, nickel and the chemical agent that cannot be adequately pre-medicated.
- Occlusive peripheral vascular disease that would preclude percutaneous femoral access for the procedure.
- Subject is depressed or on antidepressants.
- Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
- Life expectancy of less than 12 months.
- Unwilling or unable to comply with the follow-up study requirements.
- Lacking capacity to provide informed consent.
- Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety.
- Currently participation in another pre-market drug or medical device clinical study.
Trial locations and contacts
1 site in 1 country.
Paraguay1 site
Sanatorio Italiano - Centro de Intervenciones Endovasculares
Asunción
About this study
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.
Read the detailed description
Diabetes mellitus is among the most prevalent chronic diseases, affecting 435 million persons as of 2015 with an annual death toll of 1.5 million, and the overwhelming majority of these have Type 2 diabetes mellitus (T2DM). Hypertension is a common comorbidity of diabetes and present in more than 50% of diabetic patients. The risk for cardiovascular disease (CVD) is four-fold higher in patients with both DM and hypertension as compared to the normotensive non-diabetic controls. Obesity, with a prevalence of over 500 million, is another common comorbidity of diabetes. These are chronic diseases associated with increased risks of cardiovascular disease, stroke, and decreased quality of life.
Neurotronic developed a novel catheter for denervation procedure. Chemical agent is delivered locally into the adventitial space and ablates the sympathetic nerve and nerve endings in the adventitial space of the target arteries.
The purpose of the study is to assess the safety and feasibility of chemical denervation of the target arteries for the treatment of Type 2 diabetes (T2DM) and its comorbidities.
- Being tested
- The Neurotronic arterial ablation catheter
- Keywords
- Denervation, T2DM, Hypertension, Obesity
- Medical subject headings
- Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Neurotronic arterial ablation catheterDevice
Also called NAA
a sterile, single use catheter (device) for delivering chemical agent to achieve perivascular denervation.
| Study group | Role | What they receive |
|---|---|---|
| Treated by the study device | Experimental | Not described Receives: Device: The Neurotronic arterial ablation catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 30 Days post procedure
Secondary outcomes (7)
Glycemic Control (1)
Improvement of HbA1c (%) will be analyzed by absolute and relative changes. Percent subjects with decrease HbA1c will also be analyzed.
Measured: 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)
Improvement of fasting glucose (mg/dl) will be analyzed by absolute and relative changes. Percent subjects with decrease fasting glucose will also be analyzed.
Measured: 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
Improvement of blood pressure (mmHg) will be analyzed by absolute and relative changes.
Measured: 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)
The improvement of the body weight (weight in kg) will be analyzed by absolute and relative changes.
Measured: 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)
The improvement of the body weight will be analyzed by Body Mass Index (BMI in kg/m^2) absolute and relative changes.
Measured: 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.
Device Success
Device success, defined as successful introduction of the catheter, navigation to the treatment site, deployment of the features, and infusion of the chemical agent to the intended area without device malfunction that requiring abort the procedure.
Measured: during procedure or immediately after procedure
Procedure Success
Procedure success, defined as device success without any serious device- and procedure-related complications during the procedure and prior to hospital discharge.
Measured: during procedure or immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start4 Nov 2019
- Primary completion17 Jan 2023
- Study completion17 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus With Circulatory ComplciationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-center, non-randomized, open label first-in-human (FIH) study.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurotronic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Libra Medical
- Responsible party
- Sponsor
- Investigators
- John Chen, Study director, Neurotronic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232774
- Sponsor's protocol ID
- PR 2010
- Acronym
- NECTAR
- Status last verified
- Mar 2023
- First submitted
- 8 Jan 2020
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurotronic Ablation of Arteries for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities
- ClinicalTrials.gov ID
- NCT04232774
- Acronym / sponsor ID
- NECTAR / PR 2010
- Keywords
- Denervation, T2DM, Hypertension, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Neurotronic, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Libra Medical
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Diabetes mellitus is among the most prevalent chronic diseases, affecting 435 million persons as of 2015 with an annual death toll of 1.5 million, and the overwhelming majority of these have Type 2 diabetes mellitus (T2DM). Hypertension is a common comorbidity of diabetes and present in more than 50% of diabetic patients. The risk for cardiovascular disease (CVD) is four-fold higher in patients with both DM and hypertension as compared to the normotensive non-diabetic controls. Obesity, with a prevalence of over 500 million, is another common comorbidity of diabetes. These are chronic diseases associated with increased risks of cardiovascular disease, stroke, and decreased quality of life.
Neurotronic developed a novel catheter for denervation procedure. Chemical agent is delivered locally into the adventitial space and ablates the sympathetic nerve and nerve endings in the adventitial space of the target arteries.
The purpose of the study is to assess the safety and feasibility of chemical denervation of the target arteries for the treatment of Type 2 diabetes (T2DM) and its comorbidities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-center, non-randomized, open label first-in-human (FIH) study.
| Arm | Type | Receives |
|---|---|---|
| Treated by the study device | Experimental | Device: The Neurotronic arterial ablation catheter |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 22 and ≤ 70 years at time of enrollment.
- Diagnosed with uncontrolled T2DM with baseline.
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Neurotronic arterial ablation catheterAlso: NAAa sterile, single use catheter (device) for delivering chemical agent to achieve perivascular denervation. | Device | Treated by the study device |
Primary outcome
Incidence of Serious Device- and Procedure-Related Complications
Time frame: at 30 Days post procedure
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
7 secondary outcomes
Glycemic Control (1)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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.
Device Success
Time frame: during procedure or immediately after procedure
Procedure Success
Time frame: during procedure or immediately after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Chen study director
Neurotronic, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Neurotronic arterial ablation catheter in people with Type 2 Diabetes Mellitus With Circulatory Complciation, run by Neurotronic, Inc. at 1 site in Paraguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Serious Device- and Procedure-Related Complications (time frame: at 30 Days post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.