Uncontrolled Stage 2 HypertensionREDUCEDNCT05372679
REDUCED 1 - Renal Denervation Using Ultrasonic Catheter EmitteD Energy Study /
A study testing Renal denervation in people with Uncontrolled Stage 2 Hypertension, run by SoniVie Inc. at 9 sites in United States.
Trial summary
This is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System in subjects with uncontrolled stage 2 hypertension in order to assess the safety and effectiveness of the TIVUS™ System when used for renal artery denervation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Uncontrolled Stage 2 Hypertension
- What is being tested?
- Renal denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 9 sitesUnited States
- Study dates
- 11 Nov 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Written informed consent to participate in the study obtained from the patient, according to local regulations, prior to initiation of any study mandated procedure.
- Male or female, ≥ 18 years of age and ≤ 80 years of age at the time of screening.
- Individual has office systolic blood pressure (SBP) ≥ 140 mm Hg but < 180 mm Hg, and a diastolic blood pressure (DBP) ≥ 90 mm Hg but < 110 mm Hg based on an average of 3 office seated blood pressure readings measured by a manual, automated or semi-automated validated BP monitor, on current medications. 4. Documented mean daytime ABPM systolic blood pressure (SBP) ≥ 135 mm Hg but < 180 mm Hg, after a 4 week stabilization period.
- 5. Patient is either on at least one anti-hypertensive medication at maximal tolerated dose with a medically documented intolerance to one or more medications, or on three medications where one is a diuretic.
- 6. Patient is willing and expected to maintain their anti-hypertensive medication regimen for at least 3 months.
- 7. Patient is able and willing to comply with all study procedures.
Who cannot join
- Patient has been previously diagnosed with abnormal renal artery anatomy and/or renal anatomy such as single kidney, other renal development anomaly such as ectopic or horseshoe kidney, or polycystic kidney disease precluding renal denervation therapy as detailed in the angiographic exclusion criteria.
- Pregnant or breastfeeding women or women planning a pregnancy within 12 months of study enrollment.
- Patient has an estimated glomerular filtration rate (eGFR) of < 40mL/min/1.73m2 CKD-EPI as calculated using the CKD-EPI 2021 equation.
- Patients with uncontrolled rapid AF.
- Patient has had a previous renal denervation procedure.
- Patients with daytime ABPM mean systolic blood pressure (SBP) > 180 mm Hg.
Show all 37Show fewer
- Patient has Type 1 diabetes or poorly controlled Type 2 diabetes (HbA1c > 9%).
- Patients with history of myocardial infarction, unstable angina pectoris, heart failure, cerebrovascular accident, or widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
- Patient has a planned major surgery or cardiovascular intervention in the next 6 months.
- Patient who has undergone a major surgery or cardiovascular intervention in the previous 3 months.
- Patient has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment.
- Patient is taking immunosuppressive therapy for diseases featuring vasculitis.
- Patient on anticoagulant therapy that cannot be temporarily withheld for study procedure.
- Contraindication to recommended denervation procedure medications or intravascular contrast that cannot be adequately controlled with pre-medication.
- Concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints. For patient previously participating in a drug trial, allow a wash-off period of at least 5 half-lives of the investigational drug.
- Patient with significant co-morbid condition(s) which, at the discretion of the PI, are deemed to prohibit study entry.
- Patient works the night shift.
- Patient has valvular stenosis with risk of cardiac event with significant and/or abrupt decline in systolic blood pressure.
- Untreated secondary cause of hypertension.
- Device therapy within the past five years for the treatment of hypertension.
- Prior renal stent or angioplasty.
- Life expectancy <1 year.
- Patients with history of renal transplant or planned renal transplantation within the next year.
- History of one or more episodes of severe orthostatic hypotension within the past year.
- Patient has unstable cardiac or pulmonary disease (including pulmonary hypertension) requiring chronic oxygen support.
- Uncontrolled or inadequately treated bleeding diathesis.
- Evidence of active infection within 7 days of procedure
- Angiographic Exclusion Criteria
- The following characteristics identified either on the renal artery CT scan or on the Eligibility II Renal artery Angiogram will prevent the patient from being included:
- Main renal arteries < 4 mm in lumen diameter or < 20 mm in length; accessory renal arteries, if present, < 4 mm in lumen diameter or <10 mm in length.
- Aorto-renal angle that in the operator's opinion prevents a safe cannulation of the renal artery.
- Severe common femoral artery, common and/or external iliac artery, renal, iliac or aortic calcification or tortuosity that may compromise the safe performance and completion of the TIVUS™ procedure.
- Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the operator's opinion, would interfere with safe cannulation of the renal artery or meets local standards for surgical repair or interventional dilation (NOTE: vessel areas with calcification and fibromuscular dysplasia (FMD) should be avoided as intended treatment areas).
- Any renal artery stenosis > 30% by visual assessment.
- Any renal artery aneurysm (>50% of the main renal artery reference vessel diameter by visual estimate).
- Presence of fibromuscular dysplasia
- Significant renal artery atheroma, aneurysm, calcification in the target vessel identified on CT Angiogram
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Cardiology P.C.
Birmingham, Alabama, 35211
Bridgeport Hospital
Bridgeport, Connecticut, 06610
Medical University South Carolina
Charleston, South Carolina, 29425
ST Bernards Medical Center
Jonesboro, Arkansas, 72401
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Minneapolis Heart Institution Foundation
Minneapolis, Minnesota, 55407
Columbia University/NYPH
New York, New York, 10032
NC Heart and Vascular Research, LLC
Raleigh, North Carolina, 27607
Prairie Education and Research Cooperative
Springfield, Illinois, 62701
About this study
Official title: Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Renal Denervation in Patients With Uncontrolled Stage 2 Hypertension
This is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System in subjects with uncontrolled stage 2 hypertension in order to assess the safety and effectiveness of the TIVUS™ System when used for renal artery denervation. The study will assess the acute and chronic safety of the procedure as well as the reduction in 24-hour ambulatory mean systolic blood pressure from baseline to 3 months after the procedure.
Read the detailed description
Nearly half of adults in the United States (108 million, or 45%) have hypertension defined as a systolic blood pressure ≥ 130 mm Hg or a diastolic blood pressure ≥ 80 mm Hg or are taking medication for hypertension. Hypertension is associated with cardiovascular and renal pathologies and leads to death if not treated appropriately. The cardiovascular risk factor doubles with each 20/10 mm Hg elevation in BP values above 115/75 mm Hg.
The current first-line therapy for hypertension involves change in life-style (i.e., diet and exercise) and various medications. However, only about 1 in 4 treated adults (24%) with hypertension have their condition under control. Thus, they are at increased risk for the major side effects of chronically elevated blood pressure, myocardial infarction, stroke, renal disease and heart failure. High blood pressure was a primary or contributing cause of death for more than 494,873 people in the United States in 2018, and was estimated to affect around 1.13 billion people worldwide and resulted in approximately 10 million deaths worldwide, in 2015.
About half of adults (45%) with uncontrolled hypertension have a blood pressure of 140/90 mm Hg or higher, now defined as Stage 2 hypertension. This includes 37 million U.S. adults. About 30 million adults are recommended to take medication. Almost two out of three of this group (19 million) have a blood pressure of 140/90 mm Hg or higher. The other 17 million adults are taking medications but are unable to lower their blood pressure below 140/90 mm Hg and are thus at increased risk for the risks associated with uncontrolled high blood pressure9. High blood pressure costs the United States about $131 billion each year, averaged over 12 years from 2003 to 2014.
In the past decade, several devices were developed in order to target the autonomic nervous system and lower BP in patients with uncontrolled hypertension. These devices aim to provide additional treatment option for patients who do not respond to antihypertensive medication. These devices target other BP regulating mechanisms such as baroreflex activation, deep brain stimulation carotid body ablation, direct vagus nerve stimulation, cardiac neuromodulation, central iliac arteriovenous coupler as well as other devices are currently under research, however, there is no medical device that has been approved so far.
The Therapeutic Intra Vascular UltraSound (TIVUS™) System is designed for renal artery nerve ablation using transluminal ultrasound (US). The TIVUS™ System is a high intensity, non-focused, ultrasound catheter system, which enables remote, localized, controlled, and repeatable thermal modulation of nerves adjacent to arterial vessel wall for performing safe and effective therapeutic artery sympathetic denervation. The ultrasonic energy is transmitted from a catheter positioned within the artery lumen, while avoiding direct contact with the artery wall.
- Conditions
- Uncontrolled Stage 2 Hypertension
- Being tested
- Renal denervation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal denervationDevice
The TIVUS system will be used for renal denervation
| Study group | Role | What they receive |
|---|---|---|
| Renal denervation | Experimental | Denervating the sympathetic nerves surrounding the renal vasculature using unfocused ultrasound Receives: Device: Renal denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
acute treatment related adverse events including including all-cause mortality, acute kidney injury, significant embolic event, renal artery perforation or dissection requiring intervention, vascular complications, stroke, myocardial infarction, or transient ischemic attack, deterioration in renal function end-stage renal failure, hospital admission for hypertensive crisis not related to confirmed nonadherence with medications or the protocol, new renal artery stenosis of more than 70% and major access site complications or cardiovascular complications
Measured: from baseline to 1 month post procedure
Incidence of Adverse Events
chronic treatment related adverse events including including all-cause mortality, acute kidney injury, significant embolic event, renal artery perforation or dissection requiring intervention, vascular complications, stroke, myocardial infarction, or transient ischemic attack, deterioration in renal function end-stage renal failure, hospital admission for hypertensive crisis not related to confirmed nonadherence with medications or the protocol, new renal artery stenosis of more than 70% and major access site complications or cardiovascular complications
Measured: from baseline to 12 month post procedure
Change in mean daytime ambulatory systolic BP
Reduction in daytime ambulatory mean systolic blood pressure from baseline to 3 months after the procedure.
Measured: From baseline to 3 months post procedure
Secondary outcomes (14)
Change in mean 24-hr ambulatory systolic and diastolic bp
Reduction of 24-hour ambulatory mean systolic and diastolic blood pressure from baseline
Measured: 3, 6, 12, 24, 36 months
Change in mean 24-hr ambulatory diastolic bp
Reduction of 24-hour ambulatory mean diastolic blood pressure from baseline
Measured: 3 months
Change in mean daytime ambulatory systolic bp
Reduction of daylight ambulatory mean systolic blood pressure from baseline
Measured: 6, 12, 24, 36 months
Change in mean nighttime ambulatory systolic and diastolic bp
Reduction of nighttime ambulatory mean systolic and diastolic blood pressure from baseline
Measured: 3, 6, 12, 24, 36 months
Change in mean office systolic and diastolic BP
Reduction of office mean systolic and diastolic blood pressure from baseline
Measured: 3, 6, 12, 24, 36 months
Change in mean 24-hr ambulatory pulse
Reduction in mean 24-hour ambulatory pulse pressure from baseline
Measured: 3, 6, 12, 24, 36 months
Rate of patients achieving target 24-hr ambulatory mean systolic BP
Number of patients achieving target 24-hour ambulatory mean systolic blood pressure (<130 mm Hg)
Measured: 3, 6, 12, 24, 36 months
Rate of patients achieving target office systolic BP
Number of patients achieving target office systolic blood pressure (<140 mm Hg)
Measured: 3, 6, 12, 24, 36 months
Change in number of antihypertensive medications taken
Reduction in the number of antihypertensive medications taken and/or the dose taken
Measured: 6, 12 months
Percentage of patients who respond to treatment
Percentage of patients who respond to the treatment, with response defined as a reduction of at least 10mm in mean 24-hour ambulatory systolic blood pressure
Measured: 3, 6, 12 months
Incidence of hypertensive or hypotensive emergency episodes
Incidence of hypertensive or hypotensive emergency episodes resulting in hospitalization
Measured: 3, 6, 12 months
Change in renal function based on laboratory parameters
Changes in renal function, based on laboratory parameters such as eGFR (CKD-EPI) and serum creatinine
Measured: 3, 6, 12 months
Change in renal function based on artery stenosis
Changes in renal function, based on artery stenosis (>70%)
Measured: 6, 12 months
Incidence of heart failure
Episodes of heart failure events
Measured: 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start11 Nov 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled Stage 2 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multicenter, non-randomized, open-label clinical study
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SoniVie Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ajay Kirtane, MD, Principal investigator, Columbia University/NYPH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372679
- Sponsor's protocol ID
- CLNS05-001
- Acronym
- REDUCED
- Status last verified
- May 2026
- First submitted
- 9 May 2022
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Renal Denervation in Patients With Uncontrolled Stage 2 Hypertension
- ClinicalTrials.gov ID
- NCT05372679
- Acronym / sponsor ID
- REDUCED / CLNS05-001
- Conditions
- Uncontrolled Stage 2 Hypertension
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- SoniVie Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 May 2022 (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.
This is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System in subjects with uncontrolled stage 2 hypertension in order to assess the safety and effectiveness of the TIVUS™ System when used for renal artery denervation. The study will assess the acute and chronic safety of the procedure as well as the reduction in 24-hour ambulatory mean systolic blood pressure from baseline to 3 months after the procedure.
Detailed description
Nearly half of adults in the United States (108 million, or 45%) have hypertension defined as a systolic blood pressure ≥ 130 mm Hg or a diastolic blood pressure ≥ 80 mm Hg or are taking medication for hypertension. Hypertension is associated with cardiovascular and renal pathologies and leads to death if not treated appropriately. The cardiovascular risk factor doubles with each 20/10 mm Hg elevation in BP values above 115/75 mm Hg.
The current first-line therapy for hypertension involves change in life-style (i.e., diet and exercise) and various medications. However, only about 1 in 4 treated adults (24%) with hypertension have their condition under control. Thus, they are at increased risk for the major side effects of chronically elevated blood pressure, myocardial infarction, stroke, renal disease and heart failure. High blood pressure was a primary or contributing cause of death for more than 494,873 people in the United States in 2018, and was estimated to affect around 1.13 billion people worldwide and resulted in approximately 10 million deaths worldwide, in 2015.
About half of adults (45%) with uncontrolled hypertension have a blood pressure of 140/90 mm Hg or higher, now defined as Stage 2 hypertension. This includes 37 million U.S. adults. About 30 million adults are recommended to take medication. Almost two out of three of this group (19 million) have a blood pressure of 140/90 mm Hg or higher. The other 17 million adults are taking medications but are unable to lower their blood pressure below 140/90 mm Hg and are thus at increased risk for the risks associated with uncontrolled high blood pressure9. High blood pressure costs the United States about $131 billion each year, averaged over 12 years from 2003 to 2014.
In the past decade, several devices were developed in order to target the autonomic nervous system and lower BP in patients with uncontrolled hypertension. These devices aim to provide additional treatment option for patients who do not respond to antihypertensive medication. These devices target other BP regulating mechanisms such as baroreflex activation, deep brain stimulation carotid body ablation, direct vagus nerve stimulation, cardiac neuromodulation, central iliac arteriovenous coupler as well as other devices are currently under research, however, there is no medical device that has been approved so far.
The Therapeutic Intra Vascular UltraSound (TIVUS™) System is designed for renal artery nerve ablation using transluminal ultrasound (US). The TIVUS™ System is a high intensity, non-focused, ultrasound catheter system, which enables remote, localized, controlled, and repeatable thermal modulation of nerves adjacent to arterial vessel wall for performing safe and effective therapeutic artery sympathetic denervation. The ultrasonic energy is transmitted from a catheter positioned within the artery lumen, while avoiding direct contact with the artery wall.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multicenter, non-randomized, open-label clinical study
| Arm | Type | Receives |
|---|---|---|
| Renal denervation | Experimental | Device: Renal denervationDenervating the sympathetic nerves surrounding the renal vasculature using unfocused ultrasound |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent to participate in the study obtained from the patient, according to local regulations, prior to initiation of any study mandated procedure.
- Male or female, ≥ 18 years of age and ≤ 80 years of age at the time of screening.
- Individual has office systolic blood pressure (SBP) ≥ 140 mm Hg but < 180 mm Hg, and a diastolic blood pressure (DBP) ≥ 90 mm Hg but < 110 mm Hg based on an average of 3 office seated blood pressure readings measured by a manual, automated or semi-automated validated BP monitor, on current medications. 4. Documented mean daytime ABPM systolic blood pressure (SBP) ≥ 135 mm Hg but < 180 mm Hg, after a 4 week stabilization period.
- 5. Patient is either on at least one anti-hypertensive medication at maximal tolerated dose with a medically documented intolerance to one or more medications, or on three medications where one is a diuretic.
- 6. Patient is willing and expected to maintain their anti-hypertensive medication regimen for at least 3 months.
Key exclusion criteria (37 listed)
- Patient has been previously diagnosed with abnormal renal artery anatomy and/or renal anatomy such as single kidney, other renal development anomaly such as ectopic or horseshoe kidney, or polycystic kidney disease precluding renal denervation therapy as detailed in the angiographic exclusion criteria.
- Pregnant or breastfeeding women or women planning a pregnancy within 12 months of study enrollment.
- Patient has an estimated glomerular filtration rate (eGFR) of < 40mL/min/1.73m2 CKD-EPI as calculated using the CKD-EPI 2021 equation.
- Patients with uncontrolled rapid AF.
- Patient has had a previous renal denervation procedure.
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 |
|---|---|---|
| Renal denervationThe TIVUS system will be used for renal denervation | Device | Renal denervation |
Primary outcome
Incidence of Adverse Events
Time frame: from baseline to 1 month post procedure
acute treatment related adverse events including including all-cause mortality, acute kidney injury, significant embolic event, renal artery perforation or dissection requiring intervention, vascular complications, stroke, myocardial infarction, or transient ischemic attack, deterioration in renal function end-stage renal failure, hospital admission for hypertensive crisis not related to confirmed nonadherence with medications or the protocol, new renal artery stenosis of more than 70% and major access site complications or cardiovascular complications
Incidence of Adverse Events
Time frame: from baseline to 12 month post procedure
chronic treatment related adverse events including including all-cause mortality, acute kidney injury, significant embolic event, renal artery perforation or dissection requiring intervention, vascular complications, stroke, myocardial infarction, or transient ischemic attack, deterioration in renal function end-stage renal failure, hospital admission for hypertensive crisis not related to confirmed nonadherence with medications or the protocol, new renal artery stenosis of more than 70% and major access site complications or cardiovascular complications
Change in mean daytime ambulatory systolic BP
Time frame: From baseline to 3 months post procedure
Reduction in daytime ambulatory mean systolic blood pressure from baseline to 3 months after the procedure.
14 secondary outcomes
Change in mean 24-hr ambulatory systolic and diastolic bp
Time frame: 3, 6, 12, 24, 36 months
Change in mean 24-hr ambulatory diastolic bp
Time frame: 3 months
Change in mean daytime ambulatory systolic bp
Time frame: 6, 12, 24, 36 months
Change in mean nighttime ambulatory systolic and diastolic bp
Time frame: 3, 6, 12, 24, 36 months
Change in mean office systolic and diastolic BP
Time frame: 3, 6, 12, 24, 36 months
Change in mean 24-hr ambulatory pulse
Time frame: 3, 6, 12, 24, 36 months
Rate of patients achieving target 24-hr ambulatory mean systolic BP
Time frame: 3, 6, 12, 24, 36 months
Rate of patients achieving target office systolic BP
Time frame: 3, 6, 12, 24, 36 months
Change in number of antihypertensive medications taken
Time frame: 6, 12 months
Percentage of patients who respond to treatment
Time frame: 3, 6, 12 months
Incidence of hypertensive or hypotensive emergency episodes
Time frame: 3, 6, 12 months
Change in renal function based on laboratory parameters
Time frame: 3, 6, 12 months
Change in renal function based on artery stenosis
Time frame: 6, 12 months
Incidence of heart failure
Time frame: 3, 6, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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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.
Ajay Kirtane, MD principal investigator
Columbia University/NYPH
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal denervation in people with Uncontrolled Stage 2 Hypertension, run by SoniVie Inc. at 9 sites in United States.
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 6 inclusion and 37 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: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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 Adverse Events (time frame: from baseline to 1 month post procedure). The study lists 3 primary outcomes in all. 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 20 May 2026.