NCT06526858

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: DeepQure Inc. · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed description

\<Study purpose\> The purpose of this single arm interventional study is to evaluate initial safety and device design concept of HyperQureTM, laparoscopic(extravascular) renal denervation therapy, in patients with resistant hypertension on 3 or more antihypertensive medications including a diuretic The results of this study will be used to 1) prove the concept of complete ablation by Extravascular RDN and 2) develop a solid reference for a pivotal study \<Background and Hypothesis\> The HyperQureTM RDN System is developed to overcome the limitations of intravascular RDN using catheters; 1)incomplete renal denervation, 2) risk of endothelial damage due to heat transfer from inside blood vessels by intravascular access, and 3) access limitations due to vascular anatomy and vessel size. The HyperQureTM RDN System is accessed through the vascular adventitia where renal sympathetic nerves are mainly distributed by retroperitoneal laparoscopic(extravascular) approach . Since the energy is transmitted from outside of vessel by wrapping the blood vessel 360 degrees and the instrument is applicable to small vessels including branch and/or accessory vessels, it is expected that it will be possible to achieve more complete renal denervation, reduce the risk of endothelial damage, and resolve structural access limitations. \<Study plan\> Fifteen eligible adult men and women with resistant hypertension will be enrolled and will have Extravascular(laparoscopic) RDN under general anesthesia and will have 36month follow up with various BP evaluations(24hABP, Office BP and Home BP) and CTA/DUS imaging scan evaluations

Conditions

• Resistant Hypertension

Interventions

Type	Name	Description
DEVICE	HyperQureTM 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.

Timeline

• Start date: 2024-11-21
• Primary completion: 2026-06-18
• Completion: 2029-03-20
• First posted: 2024-07-30
• Last updated: 2025-12-04

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study