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

NCT06216808 | Recruiting DMC

• 1 other identifier: HQ-HTN-K01-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 7

Brief 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

Conditions

Resistant Hypertension

Outcome Measures

Primary Outcomes (1)

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

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

  from baseline to 3 months post procedure

Secondary Outcomes (13)

• Change in 24-h ASBP

  from baseline to 6, 12 months post procedure

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

  from baseline to 3, 6, 12 months post procedure

• Change in daytime ASBP and ADBP

  from baseline to 3, 6, 12 months post procedure

• Change in nighttime ASBP and ADBP

  from baseline to 3, 6, 12 months post procedure

• Change in Office Systolic Blood Pressure(SBP) and Diastolic Blood Pressure(DBP)

  from baseline to 1, 3, 6, 12 months post-procedure

Other Outcomes (1)

• Change in antihypertensive medication usage throughout the study

  from baseline to 12 months post procedure

Study Arms (1)

Laparoscopic Renal Denervation

EXPERIMENTAL

Intervention: Device: HyperQure Renal Denervation System

Device: HyperQure Renal Denervation System

Interventions

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.

Laparoscopic Renal Denervation

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are deemed eligible for this clinical trial only if they meet all of the following criteria:
• 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
• Those who meet the following blood pressure requirements:
• \[Screening 1\]
• Office systolic blood pressure (SBP) ≥ 140 mmHg
• Office diastolic blood pressure (SBP) ≥ 90 mmHg
• \[Screening 2\]
• Office SBP ≥ 140 mmHg
• Office DBP ≥ 90 mmHg
• Daytime ASBP ≥ 135 mmHg
• Those who have the ability and willingness to provide voluntary and written consent to participate in this clinical trial

You may not qualify if:

• Subjects cannot be enrolled in the clinical trial if they meet any of the following criteria
• 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
• Those with a medical history or a history of surgery/procedure that is unsuitable for renal denervation therapy
• Renal denervation therapy
• Renal artery stenting within 3 months prior to surgery
• Polycystic kidney disease (PKD)
• Atrophic kidney
• Kidney transplant
• Dialysis due to end-stage renal disease
• Any surgery performed on the both kidney
• FMD(Fibromuscular dysplasia)
• Those with a confirmed comorbidity or a history of surgery/procedure that is unsuitable for posterior retroperitoneal approach required for renal denervation therapy

Sponsors & Collaborators

• DeepQure Inc.: lead

Study Sites (7)

Chonnam National University Hospital Hwasun Hospital

Jeonam, Chonnam Province, South Korea

RECRUITING

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Hanyang University Seoul Hospital

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

RECRUITING

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

Study Officials

• SungHoo Hong, MD

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aeyoung Woo

CONTACT

82-10-7109-0205; aywoo@deepqure.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The HyperQure RDN System consists of a generator that generates RF(Radiofrequency) 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.

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: December 4, 2023
• Primary Completion: March 6, 2026
• Study Completion (Estimated): December 4, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (7)