RecruitingNot ApplicableNCT06216808

A First-in-human Study of HyperQureTM", Laparoscopic Renal Denervation Therapy in Patient With Resistant Hypertension

A Prospective, Multicenter, Single Arm, Open Label, First-in-human Study to Evaluate the Safety and Initial Efficacy of HyperQureTM, Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension on 3 or More Antihypertensive Medications


Sponsor

DeepQure Inc.

Enrollment

10 participants

Start Date

Dec 4, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

HQ-HTN-K01-02 is a prospective, multicenter, single arm, open label, first-in-human study to evaluate the safety and initial efficacy of HyperQureTM, laparoscopic denervation therapy, in patients with resistant hypertension on 3 or more antihypertensive medications


Eligibility

Min Age: 19 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human trial testing the HyperQure device — a new laparoscopic (keyhole surgery) tool for renal denervation, a procedure that cuts the nerve signals around the kidney arteries to lower blood pressure. This is for people with resistant hypertension — dangerously high blood pressure that does not come down even with 3 or more medications. **You may be eligible if...** - You are 19 to 79 years old - You have high blood pressure that remains elevated (office systolic above 140 mmHg, diastolic above 90 mmHg) despite taking 3 or more different blood pressure medications consistently, including a diuretic - Your blood pressure is confirmed elevated on a 24-hour monitoring test - You are willing to continue your current medications throughout the study **You may NOT be eligible if...** - There are structural problems in your kidney arteries (significant narrowing, stents, or plaques) that make the procedure unsafe - You have had previous renal denervation therapy - You have polycystic kidney disease, a kidney transplant, or a single kidney - You are on dialysis or have very poor kidney function - You have had recent renal artery stenting - You have conditions that make laparoscopic surgery unsafe - You are pregnant 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.

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Interventions

DEVICEHyperQure Renal Denervation 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 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 vessel is 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 is also performed on the branch or accessory vessel confirmed to be suitable for the procedure by CTA.


Locations(7)

Chonnam National University Hospital Hwasun Hospital

Jeonam, Chonnam Province, South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Asan Medical Center

Seoul, South Korea

Hanyang University Seoul Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Yonsei University Health System, Severance Hospital

Seoul, South Korea

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NCT06216808


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