Resistant HypertensionNCT06526858
Early Feasibility Study of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension
A study testing HyperQureTM Renal Denervation (RDN) System: in people with Resistant Hypertension, run by DeepQure Inc. at 6 sites in United States.
Trial summary
HQ-HTN-G01 is a prospective, multicenter, single arm, open label, early feasibility study to evaluate initial safety and device design concept of "HyperQureTM RDN System", laparoscopic renal denervation therapy, in patients with resistant hypertension on three(3) or more antihypertensive medications Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- HyperQureTM Renal Denervation (RDN) System:
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 6 sitesUnited States
- Study dates
- 21 Nov 2024to 31 Dec 2029
- 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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are eligible to participate if all of the following criteria are met:
- Aged ≥22 and ≤80 years old at time of enrollment (consent).
- Diagnosed with resistant hypertension.
- Office BP ≥140/90 mmHg at Screening Visit 1, and on at least 3 antihypertensive medications of different classes including a diuretic for at least 4 weeks prior to consent.
- Daytime ABP ≥135/85 mmHg after a four (4)-week run-in period at Screening Visit 2.
- Agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.
Who cannot join
- Subjects are not eligible to participate if any of the following criteria are met:
- Has coverage diameter of renal artery less than 2 mm or greater than 11 mm.
- Has one or more of the following conditions:
- Unstable angina with stent implantation (percutaneous coronary intervention) within 3 months of enrolment.
- Myocardial infarction within 3 months of enrollment.
- Acute heart failure (New York Heart Association (NYHA) III-IV) within 3 months of enrollment
Show all 45Show fewer
- Cerebrovascular accident or transient ischemic attack within 3 months of enrollment.
- Atrial fibrillation patients undergoing treatment and not in sinus rhythm. Notes: Patients who have received medical treatment, catheter or surgical treatment for atrial fibrillation and are in sinus rhythm are not excluded
- Has one or more of the following confirmed anatomical findings in the kidney or renal artery that are not suitable for renal denervation (assessed by the renal CT angiography of Screening 2)
- A single functioning kidney.
- An atheroma, aneurysm or renal artery stent within 5 mm of the renal denervation site.
- Presence of stenosis of 30% or more on all of the blood vessels available for renal denervation therapy.
- When it is deemed impossible to perform denervation on both renal arteries according to the discretion of the investigator.
- Has one or more of the following medical history or a history of surgery/procedure that is not suitable for renal denervation therapy
- Renal denervation therapy.
- Polycystic kidney disease (PKD).
- Atrophic kidney.
- Kidney transplant.
- Dialysis due to end-stage renal disease.
- Any surgery performed on both kidneys. (except endoscopy type of surgery, i.e. endoscopic kidney stone removal)
- FMD (Fibromuscular dysplasia)
- Has comorbidities or surgical/procedural history that are not suitable for retroperitoneal approach
- Surgical history through retroperitoneal approach.
- Fibrosis in the retroperitoneal region.
- Inflammation in the retroperitoneal region.
- Severe obesity (body mass index (BMI) > 40 kg/m2)
- Risk of increased intracranial pressure
- Has a history of any intervention for underlying renal artery pathology including stenting or balloon angioplasty.
- Individual has an eGFR of <45 mL/min/1.73m2, using the 4 variable Modification of Diet in Renal Disease (MDRD) calculation (in mL/min) per 1.73 m2 = 175 x Serum Cr-1.154 x age-0.203 x 1.212 (if patient is black) x 0.742 (if female).
- Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma Hb1Ac ≥ 9.0%).
- Has had a reduction of SBP of ≥20 mm Hg or DBP of ≥10 mm Hg within 3 minutes of standing coupled with symptoms during the screening process (at Screening Visit 2).
- Requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea (e.g., CPAP, BiPAP).
- Has documented primary pulmonary hypertension.
- Has an untreated secondary cause of hypertension (either known or suspected) or is taking drugs that increase sympathetic tone and could contribute to hypertension.
- Has a scheduled or planned surgery that, in the opinion of the Investigator, may affect study endpoints.
- Works night shifts.
- Has severe cardiac valve stenosis for which, in the opinion of the Investigator, a significant reduction of blood pressure is contraindicated.
- Is pregnant, nursing or planning to become pregnant during the course of the study follow-up (Note: Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to angiography).
- Has a known unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable, in the opinion of the Investigator, to comply with study follow-up requirements.
- Has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- Patients who are at high risk if taken off their anticoagulant and antiplatelet agents for a few days.
- Allergy, intolerance or contraindications to contrast medium.
- Prescribed any standard antihypertensive cardiovascular medication for other chronic conditions (e.g. ischemic heart disease) for less than 90 days before Screening visit 1 and whose discontinuation might pose serious risk to health.
- Has frequent intermittent or chronic pain that results in the treatment with non-steroidal anti-inflammatory drugs (NSAIDs) for two (2) or more days per week over the month prior to Screening Visit 2.
- Concurrent enrollment in any other investigational drug or device study(Participation in non-interventional Registries is acceptable).
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Janice Lea, MD, 404-686-5038, jlea@emory.edu
Janice Lea, MD
- Recruiting
Henry Forth Health
Detroit, Michigan, 48202
Syed T Ahsan, MD, 404-686-5038, sahsan4@hfhs.org
Syed T Ahsan, MD
- Recruiting
University of Florida College of Medicine
Gainesville, Florida, 32610
Segal Mark S, MD, 404-686-5038, Mark.Segal@medicine.ufl.edu
Segal Mark, MD
- Recruiting
University of California Irvine
Orange, California, 92868
Lizette Spiers, 714-465-5694, lspiers@uci.edu
Pengbo Jiang, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
George K Chow, MD
- Recruiting
Stanford Health Care
Stanford, California, 94305
Satvir Basran, 650-723-0948, sbasran@stanford.edu
Benjamin I Chung, MD
About this study
Official title: A Prospective, Multicenter, Single Arm, Open-label, Early Feasibility Study to Evaluate Initial Safety and Device Design Concept of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension on Three(3) or More Antihypertensive Medications
HQ-HTN-G01 is a prospective, multicenter, single arm, open label, early feasibility study to evaluate initial safety and device design concept of "HyperQureTM RDN System", laparoscopic renal denervation therapy, in patients with resistant hypertension on three(3) or more antihypertensive medications
Read the detailed description
<Study purpose> The purpose of this single arm interventional study is to evaluate initial safety and device design concept of HyperQureTM, laparoscopic(extravascular) renal denervation therapy, in patients with resistant hypertension on 3 or more antihypertensive medications including a diuretic The results of this study will be used to 1) prove the concept of complete ablation by Extravascular RDN and 2) develop a solid reference for a pivotal study
<Background and Hypothesis> The HyperQureTM RDN System is developed to overcome the limitations of intravascular RDN using catheters; 1)incomplete renal denervation, 2) risk of endothelial damage due to heat transfer from inside blood vessels by intravascular access, and 3) access limitations due to vascular anatomy and vessel size.
The HyperQureTM RDN System is accessed through the vascular adventitia where renal sympathetic nerves are mainly distributed by retroperitoneal laparoscopic(extravascular) approach . Since the energy is transmitted from outside of vessel by wrapping the blood vessel 360 degrees and the instrument is applicable to small vessels including branch and/or accessory vessels, it is expected that it will be possible to achieve more complete renal denervation, reduce the risk of endothelial damage, and resolve structural access limitations.
<Study plan> Fifteen eligible adult men and women with resistant hypertension will be enrolled and will have Extravascular(laparoscopic) RDN under general anesthesia and will have 36month follow up with various BP evaluations(24hABP, Office BP and Home BP) and CTA/DUS imaging scan evaluations
- Conditions
- Resistant Hypertension
- Being tested
- HyperQureTM Renal Denervation (RDN) System:
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperQureTM Renal Denervation (RDN) System:Device
Also called Extravascular renal denervation, Laparoscopic renal denervation
The HyperQure RDN System consists of a Generator that generates RF energy and a Laparoscopic Instrument that delivers the RF energy generated by the generator to the treatment area. Through a extravascular(laparoscopic) approach, the renal artery is accessed through the retroperitoneum, which is the closest path to the renal artery. After wrapping 360 degrees of renal artery, RDN is performed as per the preset parameters of 50 degrees and 70 seconds.
The target blood vessels will be planned by CTA before the procedure, and the proximal and distal areas of the right and left main renal artery are treated once at a distance of at least 3 mm respectively, and RDN will be also performed on the branch or accessory vessels confirmed to be suitable for the procedure by CTA.
| Study group | Role | What they receive |
|---|---|---|
| Extravsacular(Laparoscopic) Renal Denervation | Experimental | Intervention:
Device: HyperQureTM Renal Denervation (RDN) System:
* HyperQureTM RDN Generator
* HyperQureTM RDN Laparoscopic Instrument Receives: Device: HyperQureTM Renal Denervation (RDN) System: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in 24-h Ambulatory Systolic Blood Pressure(ASBP)
Measure by 24-hour ambulatory blood pressure monitoring(ABPM)
Measured: from baseline to 3 months post procedure
• Incidence of major adverse events (MAE). Defined as a composite of the following events, through 1-month post-procedure
- All-cause mortality.
- End-stage renal disease (ESRD).
- Significant embolic event resulting in end-organ damage
- Renal artery perforation requiring intervention.
- Renal artery dissection requiring intervention.
- Vascular complications.
- Injury to surrounding structures (inc. vasculature structure, the ureters, colon and or other intraabdominal and/or retroperitoneal structures).
- Hospitalization for hypertensive crisis not related to confirmed nonadherence with medications or the protocol.
- New renal artery stenosis >70%, as diagnosed by DUS and confirmed by Computed Tomography Angiogram (CTA) or diagnosed/confirmed by renal CTA.
- Prolongation of hospitalization after the index intervention for device or procedural related issues.
- Major bleeding (bleeding Type 3a or higher according to the Bleeding Academic Research Consortium [BARC]2; overt bleeding plus a hemoglobin drop of 3 to 5 g/dL; any transfusion with overt bleeding).
Measured: from baseline to1-month post-procedure
Secondary outcomes (9)
Change in 24-h ASBP
Measure by 24-hour ambulatory blood pressure monitoring(ABPM)
Measured: from baseline to 6-, 12-, 24-, 36-months post procedure.
Change in 24-h Ambulatory Diastolic Blood Pressure(ADBP)
Measured by 24-hour ABPM
Measured: from baseline to 3-, 6-, 12-, 24-, 36-months post procedure.
Change in daytime ASBP and ADBP
Measured by 24 hour ABPM
Measured: from baseline to 3-, 6-, 12-, 24-, 36-months post procedure
Change in nighttime ASBP and ADBP
Measured by 24 hour ABPM
Measured: from baseline to 3-, 6-, 12-, 24-, 36-months post procedure
Change in Office Systolic Blood Pressure(SBP) and Diastolic Blood Pressure(DBP)
Measured by Office BP device
Measured: from baseline to 1-, 3-, 6-, 12-, 24-, 36-months post-procedure
Change in Home Systolic Blood Pressure(SBP) and Diastolic Blood Pressure(DBP)
Measured by Home BP device
Measured: from baseline to 1-, 3-, 6-, 12-months post procedure
Incidence of achieving target office SBP (SBP <140 mmHg)
Number of achieving target office SBP measured by Office BP device
Measured: from baseline to 1-, 3-, 6-, 12-, 24-, 36-months post-procedure
Incidence of each of the following acute/procedural adverse event
- Procedural complication (≥grade 3) as per Clavien-Dindo classification.
- Significant embolic event resulting in end-organ damage.
- Renal artery perforation requiring intervention.
- Renal artery dissection requiring intervention.
- Vascular complications.
- ESRD.
- ≥40% decline in estimated glomerular filtration rate (eGFR).
- New myocardial infarction.
- New stroke.
- Renal artery re-intervention.
- Increase in serum creatine >50% from Screening Visit 2.
- Hospitalization for hypertensive crisis not related to confirmed nonadherence with medications or the protocol.
- New renal artery stenosis >70%, diagnosed by DUS and confirmed by computed tomography (CT) angiography or diagnosed/confirmed by CTA.
Measured: from baseline to 1-month post-procedure
Incidence of each of the following chronic adverse event
- All-cause mortality.
- ESRD (≥40% decline in eGFR).
- New myocardial infarction.
- New stroke.
- Renal artery re-intervention.
- Increase in serum creatine >50% from Screening Visit 2.
- Hospitalization for hypertensive crisis not related to confirmed nonadherence with medications or the protocol.
- New renal artery stenosis >70%, diagnosed by DUS and confirmed by CT angiography or diagnosed/confirmed by CTA
Measured: from baseline to 3-, 6-, 12-, 24-, 36-months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start21 Nov 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant 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
- The HyperQure RDN System consists of a Generator that generates RF(Radiofrequency) energy and a Laparoscopic Instrument that delivers the RF energy generated by the generator to the treatment area. Through a laparoscopic approach, the renal artery is accessed through the retroperitoneum, which is the closest path to the renal artery. After wrapping 360 degrees of renal artery, RDN is performed as per the preset parameters of 50 degrees and 70 seconds. The target blood vessels will be planned by CTA before the procedure, and the proximal and distal areas of the right and left main renal artery are treated once at a distance of at least 3 mm respectively, and RDN will be also performed on the branch or accessory vessels confirmed to be suitable for the RDN procedure by CTA.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DeepQure Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526858
- Sponsor's protocol ID
- HQ-HTN-G01
- Status last verified
- Aug 2026
- First submitted
- 18 Jul 2024
- Last updated
- 10 Aug 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single Arm, Open-label, Early Feasibility Study to Evaluate Initial Safety and Device Design Concept of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension on Three(3) or More Antihypertensive Medications
- ClinicalTrials.gov ID
- NCT06526858
- Acronym / sponsor ID
- HQ-HTN-G01
- Conditions
- Resistant Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- DeepQure Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 30 Jul 2024 (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.
HQ-HTN-G01 is a prospective, multicenter, single arm, open label, early feasibility study to evaluate initial safety and device design concept of "HyperQureTM RDN System", laparoscopic renal denervation therapy, in patients with resistant hypertension on three(3) or more antihypertensive medications
Detailed description
<Study purpose> The purpose of this single arm interventional study is to evaluate initial safety and device design concept of HyperQureTM, laparoscopic(extravascular) renal denervation therapy, in patients with resistant hypertension on 3 or more antihypertensive medications including a diuretic The results of this study will be used to 1) prove the concept of complete ablation by Extravascular RDN and 2) develop a solid reference for a pivotal study
<Background and Hypothesis> The HyperQureTM RDN System is developed to overcome the limitations of intravascular RDN using catheters; 1)incomplete renal denervation, 2) risk of endothelial damage due to heat transfer from inside blood vessels by intravascular access, and 3) access limitations due to vascular anatomy and vessel size.
The HyperQureTM RDN System is accessed through the vascular adventitia where renal sympathetic nerves are mainly distributed by retroperitoneal laparoscopic(extravascular) approach . Since the energy is transmitted from outside of vessel by wrapping the blood vessel 360 degrees and the instrument is applicable to small vessels including branch and/or accessory vessels, it is expected that it will be possible to achieve more complete renal denervation, reduce the risk of endothelial damage, and resolve structural access limitations.
<Study plan> Fifteen eligible adult men and women with resistant hypertension will be enrolled and will have Extravascular(laparoscopic) RDN under general anesthesia and will have 36month follow up with various BP evaluations(24hABP, Office BP and Home BP) and CTA/DUS imaging scan evaluations
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The HyperQure RDN System consists of a Generator that generates RF(Radiofrequency) energy and a Laparoscopic Instrument that delivers the RF energy generated by the generator to the treatment area. Through a laparoscopic approach, the renal artery is accessed through the retroperitoneum, which is the closest path to the renal artery. After wrapping 360 degrees of renal artery, RDN is performed as per the preset parameters of 50 degrees and 70 seconds. The target blood vessels will be planned by CTA before the procedure, and the proximal and distal areas of the right and left main renal artery are treated once at a distance of at least 3 mm respectively, and RDN will be also performed on the branch or accessory vessels confirmed to be suitable for the RDN procedure by CTA.
| Arm | Type | Receives |
|---|---|---|
| Extravsacular(Laparoscopic) Renal Denervation | Experimental | Device: HyperQureTM Renal Denervation (RDN) System:Intervention: Device: HyperQureTM Renal Denervation (RDN) System: * HyperQureTM RDN Generator * HyperQureTM RDN Laparoscopic Instrument |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥22 and ≤80 years old at time of enrollment (consent).
- Diagnosed with resistant hypertension.
- Office BP ≥140/90 mmHg at Screening Visit 1, and on at least 3 antihypertensive medications of different classes including a diuretic for at least 4 weeks prior to consent.
- Daytime ABP ≥135/85 mmHg after a four (4)-week run-in period at Screening Visit 2.
- Agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.
Key exclusion criteria (45 listed)
- Has coverage diameter of renal artery less than 2 mm or greater than 11 mm.
- Has one or more of the following conditions:
- Has one or more of the following confirmed anatomical findings in the kidney or renal artery that are not suitable for renal denervation (assessed by the renal CT angiography of Screening 2)
- Has one or more of the following medical history or a history of surgery/procedure that is not suitable for renal denervation therapy
- Has comorbidities or surgical/procedural history that are not suitable for retroperitoneal approach
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 |
|---|---|---|
| HyperQureTM Renal Denervation (RDN) System:Also: Extravascular renal denervation, Laparoscopic renal denervationThe HyperQure RDN System consists of a Generator that generates RF energy and a Laparoscopic Instrument that delivers the RF energy generated by the generator to the treatment area. Through a extravascular(laparoscopic) approach, the renal artery is accessed through the retroperitoneum, which is the closest path to the renal artery. After wrapping 360 degrees of renal artery, RDN is performed as per the preset parameters of 50 degrees and 70 seconds. The target blood vessels will be planned by CTA before the procedure, and the proximal and distal areas of the right and left main renal artery are treated once at a distance of at least 3 mm respectively, and RDN will be also performed on the branch or accessory vessels confirmed to be suitable for the procedure by CTA. | Device | Extravsacular(Laparoscopic) Renal Denervation |
Primary outcome
Decrease in 24-h Ambulatory Systolic Blood Pressure(ASBP)
Time frame: from baseline to 3 months post procedure
Measure by 24-hour ambulatory blood pressure monitoring(ABPM)
• Incidence of major adverse events (MAE). Defined as a composite of the following events, through 1-month post-procedure
Time frame: from baseline to1-month post-procedure
* All-cause mortality. * End-stage renal disease (ESRD). * Significant embolic event resulting in end-organ damage * Renal artery perforation requiring intervention. * Renal artery dissection requiring intervention. * Vascular complications. * Injury to surrounding structures (inc. vasculature structure, the ureters, colon and or other intraabdominal and/or retroperitoneal structures). * Hospitalization for hypertensive crisis not related to confirmed nonadherence with medications or the protocol. * New renal artery stenosis >70%, as diagnosed by DUS and confirmed by Computed Tomography Angiogram (CTA) or diagnosed/confirmed by renal CTA. * Prolongation of hospitalization after the index intervention for device or procedural related issues. * Major bleeding (bleeding Type 3a or higher according to the Bleeding Academic Research Consortium [BARC]2; overt bleeding plus a hemoglobin drop of 3 to 5 g/dL; any transfusion with overt bleeding).
9 secondary outcomes
Change in 24-h ASBP
Time frame: from baseline to 6-, 12-, 24-, 36-months post procedure.
Change in 24-h Ambulatory Diastolic Blood Pressure(ADBP)
Time frame: from baseline to 3-, 6-, 12-, 24-, 36-months post procedure.
Change in daytime ASBP and ADBP
Time frame: from baseline to 3-, 6-, 12-, 24-, 36-months post procedure
Change in nighttime ASBP and ADBP
Time frame: from baseline to 3-, 6-, 12-, 24-, 36-months post procedure
Change in Office Systolic Blood Pressure(SBP) and Diastolic Blood Pressure(DBP)
Time frame: from baseline to 1-, 3-, 6-, 12-, 24-, 36-months post-procedure
Change in Home Systolic Blood Pressure(SBP) and Diastolic Blood Pressure(DBP)
Time frame: from baseline to 1-, 3-, 6-, 12-months post procedure
Incidence of achieving target office SBP (SBP <140 mmHg)
Time frame: from baseline to 1-, 3-, 6-, 12-, 24-, 36-months post-procedure
Incidence of each of the following acute/procedural adverse event
Time frame: from baseline to 1-month post-procedure
Incidence of each of the following chronic adverse event
Time frame: from baseline to 3-, 6-, 12-, 24-, 36-months post-procedure
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 10 Aug 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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HyperQureTM Renal Denervation (RDN) System: in people with Resistant Hypertension, run by DeepQure Inc. at 6 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 45 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Contact Jason Jones, MS (901-451-4792, JJason@deepqure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in 24-h Ambulatory Systolic Blood Pressure(ASBP) (time frame: from baseline to 3 months post procedure). The study lists 2 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 10 Aug 2026.