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

Part of paid clinical trials in Orange, California.

Sponsor
DeepQure Inc.
Study ID
NCT06526858
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • HyperQureTM Renal Denervation (RDN) 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 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.

Study Details

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

Key Dates

Start date
Nov 21, 2024
Status verified
Nov 2025
Primary completion
Jun 18, 2026
Completion
Mar 20, 2029

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Extravsacular(Laparoscopic) Renal Denervation
    Intervention: Device: HyperQureTM Renal Denervation (RDN) System: * HyperQureTM RDN Generator * HyperQureTM RDN Laparoscopic Instrument

Primary Outcome Measure

Decrease in 24-h Ambulatory Systolic Blood Pressure(ASBP) [ Time Frame: from baseline to 3 months post procedure ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of California IrvineOrangeCalifornia92868
Lizette Spiers
[email protected]
714-465-5694
Pengbo Jiang, MD (PRINCIPAL_INVESTIGATOR)
Stanford Health CareStanfordCalifornia94305
Satvir Basran
[email protected]
650-723-0948
Benjamin I Chung, MD (PRINCIPAL_INVESTIGATOR)
University of Florida College of MedicineGainesvilleFlorida32610
Segal Mark S, MD
[email protected]
Henry Forth HealthDetroitMichigan48202
Syed T Ahsan, MD
[email protected]
Mayo ClinicRochesterMinnesota55905
George K Chow, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Orange, CA

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
University of California Irvine· Orange, CAStanford Health Care· Stanford, CAUniversity of Florida College of Medicine· Gainesville, FLHenry Forth Health· Detroit, MIMayo Clinic· Rochester, MN

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