HypertensionMODUSNCT04917393
Multi-Organ Denervation With the iRF System to RedUce Sympathetic Drive
A study testing iRF System Multi-organ Denervation in people with Hypertension and Type 2 Diabetes, run by Metavention at 2 sites in Georgia.
Trial summary
The objective of the study is to evaluate the safety of multi-organ denervation using the Integrated Radio Frequency (iRF) Denervation System. and to understand any potential improvement in hypertension and glycemic control. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Type 2 Diabetes, Metabolic Syndrome
- What is being tested?
- iRF System Multi-organ Denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesGeorgia
- Study dates
- 13 Sep 2021to 1 Oct 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 80 years old
- Office systolic blood pressure (SBP) ≥ 135 mmHg or on a stable dose of antihypertensive medication(s) for at least 30 days
- Documented daytime systolic ambulatory blood pressure (ABP) ≥ 135 and < 175 mmHg
- HbA1c ≥7.5% - ≤11.0% on a stable dose of antidiabetic medication(s) for at least 90 days
- Waist circumference ≥ 102 cm (male) and ≥ 88 cm (female)
Who cannot join
- Renal artery (RA) anatomy on either side OR common hepatic artery (CHA) anatomy, ineligible for treatment including the following:
- CHA OR RA artery diameter < 4.0 mm or > 7.0 mm
- CHA or RA length that does not allow adequate landing zone for at least one iRF balloon placement and treatment
- Only one functioning kidney
- Presence of abnormal kidney tumors
- CHA or RA with aneurysm
Show all 41Show fewer
- Pre-existing stent or history of angioplasty in target arteries
- Fibromuscular dysplasia of the CHA or renal arteries
- Presence of CHA OR RA diameter stenosis >30%
- Individual lacks appropriate arterial anatomy for treatment or for maneuvering of the device from the femoral artery to the target location(s)
- Prior renal denervation procedure
- Type 1 diabetes mellitus
- Use of insulin within 90 days prior to Index Procedure
- eGFR < 45 mL/min per 1.73 m2
- One or more documented severe hypertensive crisis (persistent or elevated hypertension > 180 mmHg accompanied by clinical symptoms) in the 90 days prior to Index Procedure
- One or more documented hyperglycemia episodes (requiring hospitalization) in the 90 days prior to Index Procedure
- One or more Severe hypoglycemic events (severe cognitive impairment requiring external assistance for recovery) in the 90 days prior to Index Procedure
- Evidence of active infection within 7 days prior to Index Procedure
- Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis
- Any history of cerebrovascular event (e.g., stroke, transient ischemic event, and cerebrovascular accident) within 6 months prior to Index Procedure
- Myocardial infarction within 6 months of Index Procedure
- Heart failure (New York Heart Association [NYHA] Class III-IV) at time of consent.
- Documented confirmed episode(s) of stable or unstable angina within 6 months prior to Index Procedure
- Documented history of persistent or permanent atrial tachyarrhythmia
- Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
- Night shift workers
- Chronic regular use (e.g., daily use) of NSAIDs for 6 months or greater. Aspirin therapy is allowed.
- Active implantable medical device (e.g., ICD or CRT-D, neuromodulator/spinal stimulator, baroreflex stimulator)
- Known Primary pulmonary hypertension (HTN) (> 60 mmHg pulmonary artery or right ventricular systolic pressure)
- Individual has known pheochromocytoma, Cushing syndrome, primary hyperaldosteronism, coarctation of the aorta, untreated hyperthyroidism, untreated hypothyroidism, or primary hyperparathyroidism. (Note: Treated hyperthyroidism and treated hypothyroidism are permissible.)
- A history of bariatric surgery, baroreflex activation therapy, or liver transplant, or these procedures are planned in the 365 days following Index Procedure
- Previous hepatobiliary surgery/intervention that in the opinion of the investigator could preclude the ability to perform denervation of the CHA
- History or diagnosis of proliferative retinopathy or advanced autonomic neuropathy (e.g., orthostatic hypotension attributable to autonomic neuropathy, a diagnosis of gastroparesis, or a clinical history strongly suggestive of delayed gastric emptying)
- ALT or AST greater than 200 U/L
- History or evidence of active / suspected chronic liver or biliary disease including Hepatitis B, Hepatitis C, autoimmune hepatitis, primary biliary cholangitis (PBC), primary sclerosing cholangitis, Wilson's disease, alpha-1-antitrypsin deficiency, hemochromatosis, drug-induced liver disease, bile duct dilation and obstruction, symptomatic gallstones, liver cancer or liver cirrhosis. Note: subjects with past symptomatic gallstones and a cholecystectomy are not excluded.
- Current or chronic pancreatitis
- Documented contraindication or allergy to contrast medium not amenable to treatment
- Limited life expectancy of < 1 year at the discretion of the investigator
- Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements or whose participation may result in data analysis confounders
- Pregnant, nursing, or planning to become pregnant (documented negative pregnancy test result required documented within a maximum of 7 days before Index Procedure for all women of childbearing potential)
- Concurrent enrollment in any other investigational drug or device trial (participation in noninterventional registries is acceptable)
Trial locations and contacts
2 sites in 1 country.
Georgia2 sites, 2 recruiting
- Recruiting
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, 0112
- Recruiting
Tbilisi Heart and Vascular Clinic
Tbilisi, 0159
About this study
Official title: Multi-Organ Denervation to RedUce Sympathetic Drive, Multi-Center, Prospective Feasibility Study - The MODUS ON MED Study
The objective of the study is to evaluate the safety of multi-organ denervation using the Integrated Radio Frequency (iRF) Denervation System. and to understand any potential improvement in hypertension and glycemic control.
Read the detailed description
This study is a prospective, single-arm, multi-center, sham contollred trial to evaluate the initial safety and performance of multi-organ denervation for the treatment of hypertension and type 2 diabetes.
- Conditions
- Hypertension, Type 2 Diabetes, Metabolic Syndrome
- Being tested
- iRF System Multi-organ Denervation, Control Procedure
- Keywords
- Renal Denervation, Hepatic Denervation
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iRF System Multi-organ DenervationDevice
If assigned to the treatment arm, subjects will remain blinded and recieve angiography prior to catheter based RF ablation to circumferentially disrupt the sympathetic nerves surrounding the target arteries
Control ProcedureOther
If assigned to the control group, subjects will remain blinded and recieve angiography of the target arteries prior to sheath removal.
| Study group | Role | What they receive |
|---|---|---|
| Multi-organ denervation | Experimental | Multi-organ (Hepatic and Renal) denervation with the Integrated Radio Frequency (iRF) Denervation System Receives: Device: iRF System Multi-organ Denervation |
| Control Arm | Sham comparator | Subjects will recieved the sham procedure Receives: Other: Control Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of SADEs
The primary safety endpoint is the incidence rate of serious adverse device effects (SADEs)
Measured: Index Procedure through 30 days.
Secondary outcomes (4)
Change in automated unobserved average office blood pressure
Change from baseline in systolic/diastolic blood pressure as indicated by average automated unobserved office blood pressure
Measured: 90, 180 and 365 days
Change in Systolic/Diastolic Blood Pressure - Ambulatory Blood Pressure Monitoring
Change from baseline in systolic/diastolic blood pressure as indicated by ambulatory blood pressure monitoring
Measured: 90, 180 and 365 days
Change in Glycemic control - HbA1c
Change from baseline in HbA1c percent
Measured: 90 days, 180 days and 365 days
Change in Glycemic control - fasting glucose
Change from baseline in fasting plasma glucose
Measured: 90 days, 180 days and 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start13 Sep 2021
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is a prospective, single-arm, multi-center, sham controlled feasibility study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Metavention
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917393
- Sponsor's protocol ID
- 2040
- Acronym
- MODUS
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2021
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Organ Denervation to RedUce Sympathetic Drive, Multi-Center, Prospective Feasibility Study - The MODUS ON MED Study
- ClinicalTrials.gov ID
- NCT04917393
- Acronym / sponsor ID
- MODUS / 2040
- Conditions
- Hypertension, Type 2 Diabetes, Metabolic Syndrome
- Keywords
- Renal Denervation, Hepatic Denervation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- MetaventionIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 8 Jun 2021 (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 objective of the study is to evaluate the safety of multi-organ denervation using the Integrated Radio Frequency (iRF) Denervation System. and to understand any potential improvement in hypertension and glycemic control.
Detailed description
This study is a prospective, single-arm, multi-center, sham contollred trial to evaluate the initial safety and performance of multi-organ denervation for the treatment of hypertension and type 2 diabetes.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study is a prospective, single-arm, multi-center, sham controlled feasibility study
| Arm | Type | Receives |
|---|---|---|
| Multi-organ denervation | Experimental | Device: iRF System Multi-organ DenervationMulti-organ (Hepatic and Renal) denervation with the Integrated Radio Frequency (iRF) Denervation System |
| Control Arm | Sham comparator | Other: Control ProcedureSubjects will recieved the sham procedure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 and ≤ 80 years old
- Office systolic blood pressure (SBP) ≥ 135 mmHg or on a stable dose of antihypertensive medication(s) for at least 30 days
- Documented daytime systolic ambulatory blood pressure (ABP) ≥ 135 and < 175 mmHg
- HbA1c ≥7.5% - ≤11.0% on a stable dose of antidiabetic medication(s) for at least 90 days
- Waist circumference ≥ 102 cm (male) and ≥ 88 cm (female)
Key exclusion criteria (41 listed)
- Renal artery (RA) anatomy on either side OR common hepatic artery (CHA) anatomy, ineligible for treatment including the following:
- Prior renal denervation procedure
- Type 1 diabetes mellitus
- Use of insulin within 90 days prior to Index Procedure
- eGFR < 45 mL/min per 1.73 m2
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 |
|---|---|---|
| iRF System Multi-organ DenervationIf assigned to the treatment arm, subjects will remain blinded and recieve angiography prior to catheter based RF ablation to circumferentially disrupt the sympathetic nerves surrounding the target arteries | Device | Multi-organ denervation |
| Control ProcedureIf assigned to the control group, subjects will remain blinded and recieve angiography of the target arteries prior to sheath removal. | Other | Control Arm |
Primary outcome
Rate of SADEs
Time frame: Index Procedure through 30 days.
The primary safety endpoint is the incidence rate of serious adverse device effects (SADEs)
4 secondary outcomes
Change in automated unobserved average office blood pressure
Time frame: 90, 180 and 365 days
Change in Systolic/Diastolic Blood Pressure - Ambulatory Blood Pressure Monitoring
Time frame: 90, 180 and 365 days
Change in Glycemic control - HbA1c
Time frame: 90 days, 180 days and 365 days
Change in Glycemic control - fasting glucose
Time frame: 90 days, 180 days and 365 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iRF System Multi-organ Denervation in people with Hypertension and Type 2 Diabetes, run by Metavention at 2 sites in Georgia.
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 5 inclusion and 41 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: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Georgia. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam Ahlstrom (1-612-814-8208, aahlstrom@metavention.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of SADEs (time frame: Index Procedure through 30 days.). 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 21 Jun 2022.