NCT06216808

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: DeepQure Inc. · Industry
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Not accepted

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

Detailed description

\< Study purpose \> The purpose of this single arm interventional study is to evaluate the safety and initial efficacy of HyperQureTM, laparoscopic renal denervation therapy, in patients with resistant hypertension on 3 or more antihypertensive medications including a diuretic \< Background and Hypothesis \> The HyperQureTM RDN(Renal Denervation) System is developed to overcome the limitations of endovascular RDN using catheters; 1)incomplete renal denervation, 2) risk of intimal damage due to intravascular access, and 3) access limitations due to vascular anatomy and size The HyperQureTM RDN System is accessed through the adventitia where renal sympathetic nerves are mainly distributed. Since energy is transmitted by wrapping the blood vessel 360 degrees, it is expected that it will be possible to achieve more complete renal denervation, reduce the risk of intimal damage, and solve structural access problems caused by the anatomy and size of the renal blood vessel. \< Study plan \> Ten eligible adult men and women with resistant hypertension will be enrolled and will have laparoscopic RDN under general anesthesia. CTA(Computed Tomographic Angiogram), blood tests, office blood pressure, 24-hour ambulatory blood pressure and QOL will be monitored to evaluate the safety and initial efficacy for 12 months after RDN procedure.

Conditions

• Resistant Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-12-04
• Primary completion: 2026-03-06
• Completion: 2026-12-04
• First posted: 2024-01-22
• Last updated: 2025-12-04

Locations

7 sites across 1 country: South Korea