Early Feasibility Study of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension

NCT06526858 | Recruiting DMC FDA Device

• 1 other identifier: HQ-HTN-G01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 5

Brief 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

Conditions

Resistant Hypertension

Outcome Measures

Primary Outcomes (2)

• Decrease in 24-h Ambulatory Systolic Blood Pressure(ASBP)

  Measure by 24-hour ambulatory blood pressure monitoring(ABPM)

  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).

  from baseline to1-month post-procedure

Secondary Outcomes (9)

• Change in 24-h ASBP

  from baseline to 6-, 12-, 24-, 36-months post procedure.

• Change in 24-h Ambulatory Diastolic Blood Pressure(ADBP)

  from baseline to 3-, 6-, 12-, 24-, 36-months post procedure.

• Change in daytime ASBP and ADBP

  from baseline to 3-, 6-, 12-, 24-, 36-months post procedure

• Change in nighttime ASBP and ADBP

  from baseline to 3-, 6-, 12-, 24-, 36-months post procedure

• Change in Office Systolic Blood Pressure(SBP) and Diastolic Blood Pressure(DBP)

  from baseline to 1-, 3-, 6-, 12-, 24-, 36-months post-procedure

Other Outcomes (1)

• Change in antihypertensive medication usage

  from baseline up to 36-months post procedure

Study Arms (1)

Extravsacular(Laparoscopic) Renal Denervation

EXPERIMENTAL

Intervention: Device: HyperQureTM Renal Denervation (RDN) System: * HyperQureTM RDN Generator * HyperQureTM RDN Laparoscopic Instrument

Device: HyperQureTM Renal Denervation (RDN) System:

Interventions

HyperQureTM Renal Denervation (RDN) System: DEVICE

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.

Also known as: Extravascular renal denervation, Laparoscopic renal denervation

Extravsacular(Laparoscopic) Renal Denervation

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• DeepQure Inc.: lead

Study Sites (5)

University of California Irvine

Orange, California, 92868, United States

RECRUITING

Stanford Health Care

Stanford, California, 94305, United States

RECRUITING

University of Florida College of Medicine

Gainesville, Florida, 32610, United States

RECRUITING

Henry Forth Health

Detroit, Michigan, 48202, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Aeyoung Woo

CONTACT

82 10 7109 0205; aywoo@deepqure.com

Jaehung Jung, MD

CONTACT

82 10 8885 4689; jhjung@deepqure.com

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 30, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): March 20, 2029
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)