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

NCT06216808 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-04

No results posted yet for this study

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

Conditions

  • Resistant Hypertension

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.

Sponsors & Collaborators

  • DeepQure Inc.

    lead INDUSTRY

Principal Investigators

  • SungHoo Hong, MD · The Catholic University of Korea

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2026-03-06
Completion
2026-12-04

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06216808 on ClinicalTrials.gov