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RECRUITING
NCT06216808
NA

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

Sponsor: DeepQure Inc.

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

19 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2023-12-04

Completion Date

2026-12-04

Last Updated

2025-12-04

Healthy Volunteers

No

Interventions

DEVICE

HyperQure 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