Actively Recruiting
A Prospective, Multicenter, Single Arm, Open Label Study to Evaluate Safety and Initial Efficacy of HyperQureTM Laparoscopic Renal Denervation Therapy in Patients With Resistant Hypertension on 3 or More Medications
Led by DeepQure Inc. · Updated on 2025-12-04
10
Participants Needed
7
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and initial effectiveness of HyperQureTM, a laparoscopic renal denervation therapy, in adults with resistant hypertension who are taking three or more blood pressure medications including a diuretic. This first-in-human, single-arm study aims to overcome limitations seen with catheter-based renal denervation by using a device that delivers energy around the renal artery from outside the vessel, potentially allowing more complete nerve treatment and reducing procedural risks. The study involves laparoscopic renal denervation using the HyperQure Renal Denervation System, which applies radiofrequency energy around the renal arteries through a minimally invasive approach under general anesthesia. Ten eligible adults will undergo this procedure, targeting specific renal artery areas planned by CT angiography. Participants will be monitored for safety and blood pressure changes over a 12-month period following the procedure. During the study, participants will have assessments including CT angiograms, blood tests, office and 24-hour ambulatory blood pressure measurements, and quality of life questionnaires at multiple time points. Researchers will track changes in systolic and diastolic blood pressure, incidence of adverse events, and heart rate from baseline up to one year. The main outcome is the change in 24-hour ambulatory systolic blood pressure measured three months after the procedure. Safety and blood pressure will continue to be monitored through 12 months post-treatment.
CONDITIONS
Brief Title
A First-in-human Study of HyperQureTM", Laparoscopic Renal Denervation Therapy in Patient With Resistant Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged between 19 and 79 years old
- Resistant hypertension on a stable regimen of at least 3 antihypertensive medications including a diuretic for at least 4 weeks before screening
- Office systolic blood pressure of 140 mmHg or higher and diastolic blood pressure of 90 mmHg or higher at screening visits
- Daytime ambulatory systolic blood pressure of 135 mmHg or higher at screening
- Ability and willingness to provide voluntary written consent to participate
You will not qualify if you...
- Anatomical kidney or renal artery conditions unsuitable for renal denervation, including atheroma or stents near the denervation site, vessel stenosis of 30% or more, or inability to perform denervation on both renal arteries
- History of renal denervation therapy, recent renal artery stenting within 3 months, polycystic kidney disease, atrophic kidney, kidney transplant, dialysis, or surgeries on both kidneys
- Medical conditions unsuitable for retroperitoneal laparoscopic approach such as prior retroperitoneal surgery, fibrosis, inflammation, extreme obesity (BMI > 40), or risk of elevated intracranial pressure
- Estimated glomerular filtration rate (eGFR) below 45 mL/min/1.73 m2
- Type 1 diabetes or uncontrolled type 2 diabetes with HbA1c of 8.0% or higher
- Use of SGLT2 inhibitors or GLP-1 agonists within 90 days before screening unless stable for over 90 days
- Significant orthostatic hypotension unless due to benign prostatic hyperplasia
- Conditions posing safety risks from blood pressure drops, including heart valve stenosis or bleeding disorders
- Difficulty measuring blood pressure accurately due to arm size or arrhythmia
- Secondary hypertension or use of sympathomimetic drugs affecting blood pressure
- Recent cardiovascular events such as myocardial infarction, angina, heart failure, stroke, or atrial fibrillation
- Primary pulmonary hypertension
- Bleeding disorders or refusal of transfusions
- Recent peptic ulcer or gastrointestinal bleeding
- Chronic oxygen or mechanical ventilation use (except sleep apnea treatment)
- Frequent use of NSAIDs for pain control
- Allergic reactions or contraindications to contrast agents
- Use of antiretroviral therapy for HIV unless hypertension was documented before treatment
- History of narcotic abuse or recent narcotic drug use
- Untreated drug or alcohol dependence impacting ability to follow study instructions
- Planned surgeries affecting study safety or efficacy
- Night shift workers
- Recent use of other investigational drugs or devices unless deemed not to affect study
- Pregnancy, lactation, or plans to become pregnant during the study
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo laparoscopic renal denervation therapy using the HyperQureTM device under general anesthesia.
1 procedure visit (in-person)
Duration - 12 months
Participants are monitored for safety and initial efficacy through blood tests, blood pressure measurements, CT angiograms, and quality of life assessments.
Multiple visits at 1, 3, 6, and 12 months post procedure (in-person)
Trial Site Locations
Total: 7 locations
1
Chonnam National University Hospital Hwasun Hospital
Jeonam, Chonnam Province, South Korea
Actively Recruiting
2
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
Actively Recruiting
3
Asan Medical Center
Seoul, South Korea
Actively Recruiting
4
Hanyang University Seoul Hospital
Seoul, South Korea
Actively Recruiting
5
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
6
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Actively Recruiting
7
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
A
Aeyoung Woo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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