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
DeepQure Inc.
10 participants
Dec 4, 2023
INTERVENTIONAL
Conditions
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
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
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)
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NCT06216808