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Early Feasibility Study of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension

NCT06526858 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-12-04

No results posted yet for this study

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

Conditions

  • Resistant Hypertension

Interventions

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.

Sponsors & Collaborators

  • DeepQure Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-21
Primary Completion
2026-06-18
Completion
2029-03-20
FDA Device
Yes

Countries

  • United States

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 NCT06526858 on ClinicalTrials.gov