RecruitingNot ApplicableNCT06526858

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

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

Sponsor

DeepQure Inc.

Enrollment

15 participants

Start Date

Nov 21, 2024

Study Type

INTERVENTIONAL

Conditions

Resistant Hypertension

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

Eligibility

Min Age: 22 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new laparoscopic (keyhole surgery) device called the HyperQure RDN System to treat resistant hypertension — high blood pressure that remains uncontrolled despite taking three or more blood pressure medications. The device works by disrupting the nerves around the renal (kidney) arteries that contribute to keeping blood pressure high, a procedure called renal denervation. **You may be eligible if...** - You are between 22 and 80 years old - You have been diagnosed with resistant hypertension, with blood pressure of 140/90 mmHg or higher despite taking at least 3 different blood pressure medications including a diuretic - Your blood pressure is still elevated after a 4-week monitoring period - You are willing to undergo the procedure and all study follow-ups **You may NOT be eligible if...** - You have had a recent heart attack, stroke, heart failure, or coronary stent placement (within 3 months) - Your kidney arteries have structural problems (stenosis, stents, or aneurysms) that make the procedure unsafe - You have had prior kidney surgery, a kidney transplant, or polycystic kidney disease - Your kidney function is below a certain threshold (eGFR under 45) - You have uncontrolled type 1 or type 2 diabetes (HbA1c of 9% or above) - You are pregnant or planning to become pregnant - You work night shifts Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEHyperQureTM Renal Denervation (RDN) System:

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.