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

ConditionResistant Hypertension

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age19-79

SponsorDeepQure Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female patients aged between 19 and 79 years old

Resistant hypertensive patients on stable regimen of at least 3 antihypertensive medications* for at least 4weeks prior Screening1 and those who are willing to continue existing antihypertensive medications during run- in period and till 3 months after surgery from Screening 1

Patients on at least 3 antihypertensive medications of different classes including diuretics

Office systolic blood pressure (SBP) ≥ 140 mmHg

Disqualifiers

Those with the following confirmed anatomical findings in the kidney or renal artery that are unsuitable for renal denervation (assessed based on the results of the renal CT angiography of Screening 2)

If there is an atheroma or renal artery stent within 5 mm of the renal denervation site

Presence of stenosis of 30% or more on all of the blood vessels available for renal denervation therapy

When it is deemed impossible to perform denervation on both renal arteries according to the discretion of the investigator

Trial design

Design model

Single group

Treatments tested in this trial

HyperQure Renal Denervation System
Device
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.

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: Laparoscopic Renal DenervationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in 24-h Ambulatory Systolic Blood Pressure(ASBP)

Change in 24-h ASBP from baseline at 3 months post procedure

Time frame

from baseline to 3 months post procedure

Secondary outcomes

Change in 24-h ASBP

Change in 24-h ASBP from baseline to 6, 12 months post procedure

Time frame

from baseline to 6, 12 months post procedure

Change in 24-h Ambulatory Diastolic Blood Pressure(ADBP)

Change in 24-h ADBP from baseline to 3, 6, 12 months post procedure

Time frame

from baseline to 3, 6, 12 months post procedure

Change in daytime ASBP and ADBP

Change in daytime ASBP and ADBP from baseline to 3, 6, 12 months post procedure

Time frame

from baseline to 3, 6, 12 months post procedure

Change in nighttime ASBP and ADBP

Change in nighttime ASBP and ADBP from baseline to 3, 6, 12 months post procedure

Time frame

from baseline to 3, 6, 12 months post procedure

Other outcomes

Change in antihypertensive medication usage throughout the study

Change in antihypertensive medication usage from baseline to 12 months post procedure

Time frame

from baseline to 12 months post procedure

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

DeepQure Inc.

Lead sponsor

Source ClinicalTrials.gov

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